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1. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author

Group, ACTIV-3 Therapeutics for Inpatients with COVID-19 Study, Self, Wesley H, Sandkovsky, Uriel, Reilly, Cavan S, Vock, David M, Gottlieb, Robert L, Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R, Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R, Hibbert, Kathryn A, Rice, Todd W, Casey, Jonathan D, Hayanga, J Awori, Badhwar, Vinay, Leshnower, Bradley G, Sharifpour, Milad, Knowlton, Kirk U, Peltan, Ithan D, Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E, Sturek, Jeffrey M, Rogers, Angela J, Files, D Clark, Mosier, Jarrod M, Gong, Michelle N, Douin, David J, Hite, R Duncan, Trautner, Barbara W, Jain, Mamta K, Gardner, Edward M, Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A, Ginde, Adit A, Brown, Samuel M, Higgs, Elizabeth S, Pett, Sarah, Weintrob, Amy C, Chang, Christina C, Murrary, Daniel D, Günthard, Huldrych F, Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N, Babiker, Abdel G, Davey, Victoria J, Kan, Virginia, Thompson, B Taylor, Gelijns, Annetine C, Neaton, James D, Lane, H Clifford, Jundgren, Jens D, Tierney, John, Barrett, Kevin, Herpin, Betsey R, Smolskis, Mary C, Voge, Susan E, McNay, Laura A, Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J, Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, and Murray, Thomas

Subjects
Clinical Trials and Supportive Activities, Lung, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adolescent, Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antibodies, Neutralizing, Double-Blind Method, Female, Humans, Male, Middle Aged, SARS-CoV-2, Treatment Outcome, COVID-19 Drug Treatment, ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group, Clinical Sciences, Medical Microbiology, Public Health and Health Services, Microbiology
Abstract

BackgroundWe aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19.MethodsIn this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov, NCT04501978.FindingsBetween Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50-72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74-1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67-1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74-1·58]; BRII-196 plus BRII-198 1·00 [0·68-1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91-1·37]) and 155 (88%) in the BRII-196 plus BRII-198 group (1·08 [0·88-1·32]). The composite safety outcome up to day 90 was met by 48 (27%) patients in the placebo group, 42 (23%) in the sotrovimab group, and 45 (26%) in the BRII-196 plus BRII-198 group. 13 (7%) patients in the placebo group, 14 (8%) in the sotrovimab group, and 15 (9%) in the BRII-196 plus BRII-198 group died up to day 90.InterpretationNeither sotrovimab nor BRII-196 plus BRII-198 showed efficacy for improving clinical outcomes among adults hospitalised with COVID-19.FundingUS National Institutes of Health and Operation Warp Speed.

Published
2022

2. Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study

Author

Sahner, David, Tierney, John, Vogel, Susan E., Herpin, Betsey R., Smolskis, Mary C., McKay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Raim, Sharon Segal, Hensely, Lisa, Lorenzo, Johsua, Mock, Rebecca, Zuckerman, Judith, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Kang, Nayon, Barrett, Kevin, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Currier, Judy, Hughes, Eric, Harrigan, Rachel H., Amos, Laura, Carlsen, Amy, Carter, Anita, Collins, Gary, Davis, Bionca, Denning, Eileen, DuChene, Alain, Eckroth, Kate, Engen, Nicole, Frase, Alex, Gandits, Greg, Grund, Birgit, Harrison, Merrie, Hurlbut, Nancy, Kaiser, Payton, Koopmeiners, Joseph, Larson, Gregg, Meger, Sue, Mistry, Shweta Sharma, Murray, Thomas, Nelson, Ray, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Siegel, Lianne, Thompson, Greg, Vock, David, Walski, Jamie, Gelijns, Annetine C., Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Burris, Sarah, Bedoya, Gabriela, Gupta, Lola, Overbey, Jessica R., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Sandkovsky, Uriel, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samatha, Wang, Samatha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Vekstein, Andrew M., Ko, Emily R., Dreyer, Grace R., Stafford, Neil, Brooks, Megan, Der, Tatyana, Witte, Marie, Gamarallage, Ruwan, Franzone, John, Ivey, Noel, Lumsden, Rebecca H., Mosaly, Nilima, Mourad, Ahmaad, Holland, Thomas L., Motta, Mary, Lane, Kathleen, McGowan, Lauren M., Stout, Jennifer, Aloor, Heather, Bragg, Kennesha M., Toledo, Barvina, McLendon-Arvik, Beth, Bussadori, Barbara, Hollister, Beth A., Griffin, Michelle, Giangiacomo, Dana M., Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Johnathan, Vonderhaar, Derek, Nossaman, Bobby, Sylvia Laudun, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Perin, Emerson, Costello, Briana, Manian, Prasad, Sohail, M. Rizwan, Postalian, Alexander, Hinsu, Punit, Watson, Carolyn, Chen, James, Fink, Melyssa, Sturgis, Lydia, Walker, Kim, Mahon, Kim, Parenti, Jennifer, Kappenman, Casey, Knight, Aryn, Sturek, Jeffrey M., Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Adams, Amy, Badhwar, Vinay, Sharma, Sunil, Peppers, Briana, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresico, Lisa, Glaze, Chad, Evans, Raquel, Di, Fang, Carlson, Shawn, Aucremanne, Tanja, Tennant, Connie, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Williams, Roger, Bunner, Robin, Traverse, Jay H., Rhame, Frank, Huelster, Joshua, Kethireddy, Rajesh, Davies, Irena, Salamanca, Julianne, Majeski, Christine, Skelton, Paige, Zarambo, Maria, Sarafolean, Andrea, Bowdish, Michael E., Borok, Zea, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, Mary, Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Loxano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Quesada, Christine, Hamilton, Luke, Escobar, Jose, Leshnower, Brad, Bender, William, Sharifpour, Milad, Miller, Jeffrey, Farrington, Woodrow, Baio, Kim T., McBride, Mary, Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elisabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberly, Audette, Mathew, Fleischmann, Emily, Akbari, Kreshta, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nyguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Johnson, Haley, Newton, Crystallee, Parr, Doug, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Moroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Walker-Ignasiak, Rebecca, North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Muzikansky, Ariela, Morse, Richard, Fitzgerald, Laura, Morin, Haley D., Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Steingrub, Jay H., Hou, Peter K., Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Romain, Sarah, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Andromidas, Konstantinos, Banner-Goodspeed, Valerie, Bolstad, Michael, Boyle, Katherine L., Cabrera, Payton, deVilla, Arnaldo, Ellis, Joshua C., Grafals, Ana, Hayes, Sharon, Higgins, Conor, Kurt, Lisa, Kurtzman, Nicholas, Redman, Kimberly, Rosseto, Elinita, Scaffidi, Douglas, Filbin, Michael R., Hibbert, Kathryn A., Parry, Blair, Margolin, Justin, Hillis, Brooklynn, Hamer, Rhonda, Brait, Kelsey, Beakes, Caroline, McKaig, Brenna, Kugener, Eleonore, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah, Hendey, Gregory, Kangelaris, Kirsten, Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Yee, Kimberley J., Jauregui, Alejandra E., Zhuo, Hanjing, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Lim, George W., Chang, Steven Y., Lin, Michael Y., Vargas, Julia, Sihota, Hena, Beutler, Rebecca, Agarwal, Trisha, Wilson, Jennifer G., Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan H., Roque, Jonasel, Wang, Henry, Huebinger, Ryan M., Patel, Bela, Vidales, Elizabeth, Albertson, Timothy, Hardy, Erin, Harper, Richart, Moss, Marc A., Baduashvili, Amiran, Chauhan, Lakshmi, Douin, David J., Martinez, Flora, Finck, Lani L., Bastman, Jill, Howell, Michelle, Higgins, Carrie, McKeehan, Jeffrey, Finigan, Jay, Stubenrauch, Peter, Janssen, William J., Griesmer, Christine, VerBurg, Olivia, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jimenez, Jose, Olbrich, Norman, McDonough, Kelli, Jia, Shijing, Hanna, Sinan, Gong, Michelle N., Richardson, Lynne D., Nair, Rahul, Lopez, Brenda, Amosu, Omowunmi, Offor, Obiageli, Tzehaie, Hiwet, Nkemdirim, William, Boujid, Sabah, Mosier, Jarrod M., Hypes, Cameron, Campbell, Elizabeth Salvagio, Bixby, Billie, Gilson, Boris, Lopez, Anitza, Bime, Christian, Parthasarathy, Sairam, Cano, Ariana M., Hite, R. Duncan, Terndrup, Thomas E., Wiedemann, Herbert P., Hudock, Kristin, Tanzeem, Hammad, More, Harshada, Martinkovic, Jamie, Sellers, Susan, Houston, Judy, Burns, Mary, Kiran, Simra, Roads, Tammy, Kennedy, Sarah, Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Dugar, Siddharth, Sahoo, Debasis, Yealy, Donald M., Angus, Derek C., Weissman, Alexandra J., Vita, Tina M., Berryman, Emily, Hough, Catherine L., Khan, Akram, Krol, Olivia F., Mills, Emmanuel, Kinjal, Mistry, Briceno, Genesis, Reddy, Raju, Hubel, Kinsley, Jouzestani, Milad K., McDougal, Madeline, Deshmukh, Rupali, Johnston, Nicholas J., Robinson, Bryce H., Gundel, Staphanie J., Katsandres, Sarah C., Chen, Peter, Torbati, Sam S., Parimon, Tanyalak, Caudill, Antonina, Mattison, Brittany, Jackman, Susan E., Chen, Po-En, Bayoumi, Emad, Ojukwu, Cristabelle, Fine, Devin, Weissberg, Gwendolyn, Isip, Katherine, Choi-Kuaea, Yunhee, Mehdikhani, Shaunt, Dar, Tahir B., Fleury Augustin, Nsole Biteghe, Tran, Dana, Dukov, Jennifer Emilow, Matusov, Yuri, Choe, June, Hindoyan, Niree A., Wynter, Timothy, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Caudill, Antonia, O’Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Miller, Chadwick, Files, D. Clark, Gibbs, Kevin W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Palacios, D. Rafael, Parks, Lisa, Hicks, Madeline, Goodwin, Andrew J., Kilb, Edward F., Lematty, Caitlan T., Patti, Kerilyn, Grady, Abigail, Rasberry, April, Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sarah N., Mayer, Kirby P., Pharm.D., Brittany Bissel, Trott, Terren, Rehman, Shahnaz, de Wit, Marjolein, Mason, Jessica, Bledsoe, Joseph, Knowlton, Kirk U., Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Pelton, Ithan, Armbruster, Brent P., Montgomery, Quinn, Kumar, Naresh, Fergus, Melissa, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Klippel, Carolyn, Jensen, Hannah, Duckworth, Sarah, Gray, Andrew, Burke, Tyler, Knox, Dan, Lumpkin, Jenna, Aston, Valerie T., Applegate, Darrin, Serezlic, Erna, Brown, Katie, Merril, Mardee, Harris, Estelle S., Middleton, Elizabeth A., Barrios, Macy A.G., Greer, Jorden, Schmidt, Amber D., Webb, Melissa K., Paine, Roert, Callahan, Sean J., Waddoups, Lindsey J., Yamane, Misty B., Self, Wesley H., Rice, Todd W., Casey, Jonathan D., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Menon, Vidya, Kasubhai, Moiz, Pillai, Anjana, Daniel, Jean, Sittler, Daniel, Kanna, Balavenkatesh, Jilani, Nargis, Amaro, Francisco, Santana, Jessica, Lyakovestsky, Aleksandr, Madhoun, Issa, Desroches, Louis Marie, Amadon, Nicole, Bahr, Alaa, Ezzat, Imaan, Guerrero, Maryanne, Padilla, Joane, Fullmer, Jessie, Singh, Inderpreet, Ali Shah, Syed Hamad, Narang, Rajeev, Mock, Polly, Shadle, Melissa, Hernandez, Brenda, Welch, Kevin, Payne, Andrea, Ertl, Gabriela, Canario, Daniel, Barrientos, Isabel, Goss, Danielle, DeVries, Mattie, Folowosele, Ibidolapo, Garner, Dorothy, Gomez, Mariana, Price, Justin, Bansal, Ekta, Wong, Jim, Faulhaber, Jason, Fazili, Tasaduq, Yeary, Brian, Ndolo, Ruth, Bryant, Christina, Smigeil, Bridgette, Robinson, Philip, Najjar, Rana, Jones, Patrice, Nguyen, Julie, Chin, Christina, Taha, Hassan, Najm, Salah, Smith, Christopher, Moore, Jason, Nassar, Talal, Gallinger, Nick, Christian, Amy, Mauer, D’Amber, Phipps, Ashley, Waters, Michael, Zepeda, Karla, Coslet, Jordan, Landazuri, Rosalynn, Pineda, Jacob, Uribe, Nicole, Garcia, Jose Ruiz, Barbabosa, Cecilia, Sandler, Kaitlyn, Overcash, J. Scott, Marquez, Adrienna, Chu, Hanh, Lee, Kia, Quillin, Kimberly, Garcia, Andrea, Lew, Pauline, Rogers, Ralph, Shehadeh, Fadi, Mylona, Evangelia K., Kaczynski, Matthew, Tran, Quynh-Lam, Benitez, Gregorio, Mishra, Biswajit, Felix, Lewis Oscar, Vafea, Maria Tsikala, Atalla, Eleftheria, Davies, Robin, Hedili, Salma, Monkeberg, Maria Andrea, Tabler, Sandra, Harrington, Britt, Meegada, Sreenath, Koripalli, Venkata Sandeep, Muddana, Prithvi, Jain, Lakshay, Undavalli, Chaitanya, Kavya, Parasa, Ibiwoye, Mofoluwaso, Akilo, Hameed, Lovette, Bryce D., Wylie, Jamie-Crystal, Smith, Diana M., Poon, Kenneth, Eckardt, Paula, Heysu, Rubio-Gomez, Sundararaman, Nithya, Alaby, Doris, Sareli, Candice, Sánchez, Adriana, Popielski, Laura, Kambo, Amy, Viens, Kimberley, Turner, Melissa, Vjecha, Michael J., Weintrob, Amy, Brar, Indira, Markowitz, Norman, Pastor, Erika, Corpuz, Roweena, Alangaden, George, McKinnon, John, Ramesh, Mayur, Herc, Erica, Yared, Nicholas, Lanfranco, Odaliz Abreu, Rivers, Emanuel, Swiderek, Jennifer, Gupta, Ariella Hodari, Pabla, Pardeep, Eliya, Sonia, Jazrawi, Jehan, Delor, Jeremy, Desai, Mona, Cook, Aaron, Jaehne, Anja Kathrina, Gill, Jasreen Kaur, Renaud, Sheri, Sarveswaran, Siva, Gardner, Edward, Scott, James, Bianchini, Monica, Melvin, Casey, Kim, Gina, Wyles, David, Kamis, Kevin, Miller, Rachel, Douglas, Ivor, Haukoos, Jason, Hicks, Carrie, Lazarte, Susana, Marines-Price, Rubria, Osuji, Alice, Agbor Agbor, Barbine Tchamba, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Garcia, Angie, Cha, Christine, Mozaffari, Azadeh, Hernandez, Rosa, Cutrell, James, Kim, Mina, DellaValle, Natalie, Gonzales, Sonia, Somboonwit, Charurut, Oxner, Asa, Guerra, Lucy, Hayes, Michael, Nguyen, Thi, Tran, Thanh, Pinto, Avenette, Hatlen, Timothy, Anderson, Betty, Zepeda-Gutierrez, Ana, Martin, Dannae, Temblador, Cindi, Cuenca, Avon, Tanoviceanu, Roxanne, Prieto, Martha, Guerrero, Mario, Daar, Eric, Correa, Ramiro, Hartnell, Gabe, Wortmann, Glenn, Doshi, Saumil, Moriarty, Theresa, Gonzales, Melissa, Garman, Kristin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Driver, Brian, Frank, Christine, Leviton, Tzivia, Prekker, Matthew, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Kunisaki, Ken M., Wendt, Chris, Melzer, Anne, Wetherbee, Erin, Drekonja, Dimitri, Pragman, Alexa, Hamel, Aimee, Thielen, Abbie, Hassler, Miranda, Walquist, Mary, Augenbraun, Michael, George, Jensen, Demeo, Lynette, Mishko, Motria, Thomas, Lorraine, Tatem, Luis, Dehovitz, Jack, Abassi, Mahsa, Leuck, Anne-Marie, Rao, Via, Pullen, Matthew, Luke, Darlette, LaBar, Derek, Christiansen, Theresa, Howard, Diondra, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Davis-Karim, Anne, Pittman, David, Vasudeva, Shikha S., Johnstone, Jaylynn R., Agnetti, Kate, Davis, Ruby, Trautner, Barbara, Hines-Munson, Casey, Van, John, Dillon, Laura, Wang, Yiqun, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Caldwell, Erin, Humerickhouse, Edward, Boone, David, McGraw, William, Looney, David J., Mehta, Sanjay R., Johns, Scott Thompson, St. John, Melissa, Raceles, Jacqueline, Sear, Emily, Funk, Stephen, Cesarini, Rosa, Fang, Michelle, Nicalo, Keith, Drake, Wonder, Jones, Beatrice, Holtman, Teresa, Nguyen, Hien H., Maniar, Archana, Johnson, Eric A., Nguyen, Lam, Tran, Michelle T., Barrett, Thomas W., Johnston, Tera, Huggins, John T., Beiko, Tatsiana Y., Hughes, Heather Y., McManigle, William C., Tanner, Nichole T., Washburn, Ronald G., Ardelt, Magdalena, Tuohy, Patricia A., Mixson, Jennifer L., Hinton, Charles G., Thornley, Nicola, Allen, Heather, Elam, Shannon, Boatman, Barry, Baber, Brittany J., Ryant, Rudell, Roller, Brentin, Nguyen, Chinh, Mikail, Amani Morgan, Research, Marivic Hansen, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Holodniy, Mark, Chary, Aarthi, Lu, Kan, Peters, Theresa, Lopez, Jessica, Tan, Susanna Yu, Lee, Robert H., Asghar, Aliya, Karyn Isip, Tasadduq Karim, Le, Katherine, Nguyen, Thao, Wong, Shinn, Raben, Dorthe, Murray, Daniel D., Jensen, Tomas O., Peters, Lars, Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Olsson, Christina, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esman, Frederik V.L., Benfield, Thomas, Clausen, Clara Lundetoft, Hovmand, Nichlas, Israelsen, Simone Bastrup, Iversen, Katrine, Leding, Caecilie, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Tingsgard, Sandra, Krohn-Dehli, Louise, Pedersen, Dorthe, Villadsen, Signe, Staehr Jensen, Jens-Ulrik, Overgaard, Rikke, Rastoder, Ema, Heerfordt, Christian, Hedsund, Caroline, Ronn, Christian Phillip, Kamstrup, Peter Thobias, Hogsberg, Dorthe Sandbaek, Bergsoe, Christina, Søborg, Christian, Hissabu, Nuria M.S., Arp, Bodil C., Ostergaard, Lars, Staerke, Nina Breinholt, Yehdego, Yordanos, Sondergaard, Ane, Johansen, Isik S., Pedersen, Andreas Arnholdt, Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Holden, Inge K., Lindvig, Susan O., Helleberg, Marie, Gerstoft, Jan, Kirk, Ole, Jensen, Tomas Ostergaard, Madsen, Birgitte Lindegaard, Pedersen, Thomas Ingemann, Harboe, Zitta Barrella, Roge, Birgit Thorup, Hansen, Thomas Michael, Glesner, Matilde Kanstrup, Lofberg, Sandra Valborg, Nielsen, Ariella Denize, Leicht von Huth, Sebastian, Nielsen, Henrik, Thisted, Rikke Krog, Petersen, Kristine Toft, Juhl, Maria Ruwald, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Clara Ellinor Lindnér, Cecilia Ebba, Wiese, Lothar, Knudsen, Lene Surland, Skrøder Nytofte, Nikolaj Julian, Havmøller, Signe Ravn, Expósito, Maria, Badillo, José, Martínez, Ana, Abad, Elena, Chamorro, Ana, Figuerola, Ariadna, Mateu, Lourdes, España, Sergio, Lucero, Maria Constanza, Santos, José Ramón, Lladós, Gemma, Lopez, Cristina, Carabias, Lydia, Molina-Morant, Daniel, Loste, Cora, Bracke, Carmen, Siles, Adrian, Fernández-Cruz, Eduardo, Di Natale, Marisa, Padure, Sergiu, Gomez, Jimena, Ausin, Cristina, Cervilla, Eva, Balastegui, Héctor, Sainz, Carmen Rodríguez, Lopez, Paco, Carbone, Javier, Escobar, Mariam, Balerdi, Leire, Legarda, Almudena, Roldan, Montserrat, Letona, Laura, Muñoz, José, Camprubí, Daniel, Arribas, Jose R., Sánchez, Rocio Montejano, Díaz-Pollán, Beatriz, Stewart, Stefan Mark, Garcia, Irene, Borobia, Alberto, Mora-Rillo, Marta, Estrada, Vicente, Cabello, Noemi, Nuñez-Orantos, M.J., Sagastagoitia, I., Homen, J.R., Orviz, E., Montalvá, Adrián Sánchez, Espinosa-Pereiro, Juan, Bosch-Nicolau, Pau, Salvador, Fernando, Burgos, Joaquin, Morales-Rull, Jose Luis, Moreno Pena, Anna Maria, Acosta, Cristina, Solé-Felip, Cristina, Horcajada, Juan P., Sendra, Elena, Castañeda, Silvia, López-Montesinos, Inmaculada, Gómez-Junyent, Joan, Gonzáles, Carlota Gudiol, Cuervo, Guilermo, Pujol, Miquel, Carratalà, Jordi, Videla, Sebastià, Günthard, Huldrych, Braun, Dominique L., West, Emily, M’Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, pharmacist, Goes pharmacist, Josefine, Fätkenheuer, Gerd, Malin, Jakob J., Tsertsvadze, Tengiz, Abutidze, Akaki, Chkhartishvili, Nikoloz, Metchurtchlishvili, Revaz, Endeladze, Marina, Paciorek, Marcin, Bursa, Dominik, Krogulec, Dominika, Pulik, Piotr, Ignatowska, Anna, Horban, Andrzej, Bakowska, Elzbieta, Kowaska, Justyna, Bednarska, Agnieszka, Jurek, Natalia, Skrzat-Klapaczynska, Agata, Bienkowski, Carlo, Hackiewicz, Malgorzata, Makowiecki, Michal, Platowski, Antoni, Fishchuk, Roman, Kobrynska, Olena, Levandovska, Khrystyna, Kirieieva, Ivanna, Kuziuk, Mykhailo, Naucler, Pontus, Perlhamre, Emma, Mazouch, Lotta, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina C., Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David C., Ong, Sean W.X., Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Yeo, He Ping, Eriobu, Nnakelu, Kwaghe, Vivian, Zaiyad, Habib, Idoko, Godwin, Uche, Blessing, Selvamuthu, Poongulali, Kumarasamy, Nagalingeswaran, Beulah, Faith Ester, Govindarajan, Narayan, Mariyappan, Kowsalya, Losso, Marcelo H., Abela, Cecilia, Moretto, Renzo, Belloc, Carlos G., Ludueña, Jael, Amar, Josefina, Toibaro, Javier, Macias, Laura Moreno, Fernandez, Lucia, Frare, Pablo S., Chaio, Sebastian R., Pachioli, Valeria, Timpano, Stella M., Sanchez, Marisa del Lujan, de Paz Sierra, Mariana, Stanek, Vanina, Belloso, Waldo, Cilenti, Flavia L., Valentini, Ricardo N., Stryjewski, Martin E., Locatelli, Nicolas, Soler Riera, Maria C., Salgado, Clara, Baeck, Ines M., Di Castelnuovo, Valentina, Zarza, Stella M., Hudson, Fleur, Parmar, Mahesh K.B., Goodman, Anna L., Dphil, Badrock, Jonathan, Gregory, Adam, Goodall, Katharine, Harris, Nicola, Wyncoll, James, Bhagani, S., Rodger, A., Luntiel, A., Patterson, C., Morales, J., Witele, E., Preston, A.-M., Nandani, A., Price, D.A., Hanrath, Aiden, Nell, Jeremy, Patel, Bijal, Hays, Carole, Jones, Geraldine, Davidson, Jade, Bawa, T., Mathews, M., Mazzella, A., Bisnauthsing, K., Aguilar-Jimenez, L., Borchini, F., Hammett, S., Touloumi, Giota, Pantazis, Nikos, Gioukari, Vicky, Souliou, Tania, Antoniadou, A., Protopapas, K., Kavatha, D., Grigoropoulou, S., Oikonomopoulo, C., Moschopoulos, C., Koulouris, N.G., Tzimopoulos, K., Koromilias, A., Argyraki, K., Lourida, P., Bakakos, P., Kalomenidis, I., Vlachakos, V., Barmparessou, Z., Balis, E., Zakynthinos, S., Sigala, I., Gianniou, N., Dima, E., Magkouta, S., Synolaki, E., Konstanta, S., Vlachou, M., Stathopoulou, P., Panagopoulos, P., Petrakis, V., Papazoglou, D., Tompaidou, E., Isaakidou, E., Poulakou, G., Rapti, V., Leontis, K., Nitsotolis, T., Athanasiou, K., Syrigos, K., Kyriakoulis, K., Trontzas, I., Arfara-Melanini, M., Kolonis, V., Kityo, Cissy, Mugerwa, Henry, Kiweewa, Francis, Kimuli, Ivan, Lukaakome, Joseph, Nsereko, Christoher, Lubega, Gloria, Kibirige, Moses, Nakahima, William, Wangi, Deus, Aguti, Evelyne, Generous, Lilian, Massa, Rosemary, Nalaki, Margaret, Magala, Felix, Nabaggala, Phiona Kaweesi, Kidega, Robert, Faith, Oryem Daizy, Florence, Apio, Emmanuel, Ocung, Beacham, Mugoonyi Paul, Geoffrey, Amone, Nakiboneka, Dridah, Apiyo, Paska, Kirenga, Bruce, Atukunda, Angella, Muttamba, Winters, Remmy, Kyeyume, Segawa, Ivan, Pheona, Nsubuga, Kigere, David, Mbabazi, Queen Lailah, Boersalino, Ledra, Nyakoolo, Grace, Fred, Aniongo, Alupo, Alice, Ebong, Doryn, Monday, Edson, Nalubwama, Ritah Norah, Kainja, Milton, Ambrose, Munu, Kwehayo, Vanon, Nalubega, Mary Grace, Ongoli, Augustine, Obbo, Stephen, Sebudde, Nicholus, Alaba, Jeniffer, Magombe, Geoffrey, Tino, Harriet, Obonya, Emmanuel, Lutaakome, Joseph, Kitonsa, Jonathan, Onyango, Martin, Naboth, Tukamwesiga, Naluyinda, Hadijah, Nanyunja, Regina, Irene, Muttiibwa, Jane, Biira, Wimfred, Kyobejja, Leonard, Ssemazzi, Deus, Tkiinomuhisha, Babra, Namasaba, Taire, Paul, Nabankema, Evelyn, Ogavu, Joseph, Mugerwa, Oscar, Okoth, Ivan, Mwebaze, Raymond, Mugabi, Timothy, Makhoba, Anthony, Arikiriza, Phiona, Theresa, Nabuuma, Nakayima, Hope, Frank, Kisuule, Ramgi, Patrícia, Pereira, Kássia, Osinusi, Anu, Cao, Huyen, Klekotka, Paul, Price, Karen, Nirula, Ajay, Osei, Suzette, Tipple, Craig, Wills, Angela, Peppercorn, Amanda, Watson, Helen, Gupta, Rajesh, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Margolis, David, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Zhu, Quing, Seegobin, Seth, Gibbs, Michael, Latchman, Mickel, Hasior, Katarzyna, Bouquet, Jerome, Wei, Jianxin, Streicher, Katie, Schmelzer, Albert, Brooks, Dennis, Butcher, Jonny, Tonev, Dimitar, Arbetter, Douglas, Damstetter, Philippe, Legenne, Philippe, Stumpp, Michael, Goncalves, Susana, Ramanathan, Krishnan, Chandra, Richa, Baseler, Beth, Teitelbaum, Marc, Schechner, Adam, Holley, H. Preston, Jankelevich, Shirley, Becker, Nancy, Dolney, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Asomah, Mabel, Jato, Yvonne, Stottlemyer, April, Tang, Olivia, Vanderpuye, Sharon, Yeon, Lindsey, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonald, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Schaffhauser, Marylu, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, C.K., Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Kopka, Stacey, Shelley, Denise M., Mendez, Gregg, Brown, Shawn, Albert, Sara, Balde, Abby, Baracz, Michelle, Bielica, Mona, Billouin-Frazier, Shere, Choudary, Jay, Dixon, Mary, Eyler, Carolyn, Frye, Leanne, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hogarty, Debi, Huber, Lynda, Krauss, Gary, Lake, Eileen, Manandhar, Meryan, Rudzinski, Erin, Sandrus, Jen, Suders, Connie, Natarajan, Ven, Rupert, Adam W., Baseler, Michael, Lynam, Danielle, Imamichi, Tom, Laverdure, Sylvain, McCormack, Ashley, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Khan, Ayub, Hazen, Allison, Badralmaa, Yunden, Smith, Kenneth, Patel, Bhakti, Kubernac, Amanda, Kubernac, Robert, Hoover, Marie L., Solomon, Courtney, Rashid, Marium, Murphy, Joseph, Brown, Craig, DuChateau, Nadine, Ellis, Sadie, Flosi, Adam, Fox, Lisa, Johnson, Les, Nelson, Rich, Stojanovic, Jelena, Treagus, Amy, Wenner, Christine, Williams, Richard, Jensen, Tomas O, Murray, Thomas A, Grandits, Greg A, Jain, Mamta K, Shaw-Saliba, Kathryn, Matthay, Michael A, Baker, Jason V, Dewar, Robin L, Goodman, Anna L, Hatlen, Timothy J, Highbarger, Helene C, Lallemand, Perrine, Leshnower, Bradley G, Looney, David, Moschopoulos, Charalampos D, Murray, Daniel D, Mylonakis, Eleftherios, Rehman, M Tauseef, Rupert, Adam, Stevens, Randy, Turville, Stuart, Wick, Katherine, Lundgren, Jens, and Ko, Emily R

Published
2024
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3. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

Author

Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, and Krishnan, Vidya

Subjects
Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Hematology, Transplantation, Good Health and Well Being, Adult, Aged, Anticoagulants, COVID-19, Female, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Hospital Mortality, Humans, Male, Middle Aged, Survival Analysis, Thrombosis, COVID-19 Drug Treatment, ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

4. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.

Author

ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, and King, Andrew J

Subjects
ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Humans, Thrombosis, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Anticoagulants, Hospital Mortality, Survival Analysis, Adult, Aged, Middle Aged, Female, Male, COVID-19, Hematology, Clinical Trials and Supportive Activities, Transplantation, Clinical Research, Cardiovascular, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

5. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, Wenner, Christine, Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, and Lane, H Clifford

Published
2023
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6. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Author

Ginde, Adit A., Paredes, Roger, Murray, Thomas A., Engen, Nicole, Grandits, Greg, Vekstein, Andrew, Ivey, Noel, Mourad, Ahmad, Sandkovsky, Uriel, Gottlieb, Robert L., Berhe, Mezgebe, Jain, Mamta K., Marines-Price, Rubria, Agbor Agbor, Barbine Tchamba, Mateu, Lourdes, España-Cueto, Sergio, Lladós, Gemma, Mylonakis, Eleftherios, Rogers, Ralph, Shehadeh, Fadi, Filbin, Michael R., Hibbert, Kathryn A., Kim, Kami, Tran, Thanh, Morris, Peter E., Cassity, Evan P., Trautner, Barbara, Pandit, Lavannya M., Knowlton, Kirk U., Leither, Lindsay, Matthay, Michael A., Rogers, Angela J., Drake, Wonder, Jones, Beatrice, Poulakou, Garyfallia, Syrigos, Konstantinos N., Fernández-Cruz, Eduardo, Natale, Marisa Di, Almasri, Eyad, Balerdi-Sarasola, Leire, Bhagani, Sanjay R., Boyle, Katherine L., Casey, Jonathan D., Chen, Peter, Douin, David J., Files, D. Clark, Günthard, Huldrych F., Hite, R. Duncan, Hyzy, Robert C., Khan, Akram, Kibirige, Moses, Kidega, Robert, Kiweewa, Francis, Jensen, Jens-Ulrik, Leshnower, Bradley G., Lutaakome, Joseph K., Manian, Prasad, Menon, Vidya, Morales-Rull, Jose Luis, O'Mahony, D. Shane, Overcash, J. Scott, Ramachandruni, Srikant, Steingrub, Jay S., Taha, Hassan S., Waters, Michael, Young, Barnaby E., Phillips, Andrew N., Murray, Daniel D., Jensen, Tomas O., Padilla, Maria L., Sahner, David, Shaw-Saliba, Katy, Dewar, Robin L., Teitelbaum, Marc, Natarajan, Ven, Rehman, M. Tauseef, Pett, Sarah, Hudson, Fleur, Touloumi, Giota, Brown, Samuel M., Self, Wesley H., Chang, Christina C., Sánchez, Adriana, Weintrob, Amy C., Hatlen, Timothy, Grund, Birgit, Sharma, Shweta, Reilly, Cavan S., Garbes, Pedro, Esser, Mark T., Templeton, Alison, Babiker, Abdel G., Davey, Victoria J., Gelijns, Annetine C., Higgs, Elizabeth S., Kan, Virginia, Matthews, Gail, Thompson, B. Taylor, Neaton, James D., Lane, H. Clifford, and Lundgren, Jens D.

Published
2022
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7. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome

Author

Moss, Marc, Huang, David T, Brower, Roy G, Ferguson, Niall D, Ginde, Adit A, Gong, MN, Grissom, Colin K, Gundel, Stephanie, Hayden, Douglas, Hite, R Duncan, Hou, Peter C, Hough, Catherine L, Iwashyna, Theodore J, Khan, Akram, Liu, Kathleen D, Talmor, Daniel, Thompson, B Taylor, Ulysse, Christine A, Yealy, Donald M, and Angus, Derek C

Subjects
Clinical Research, Lung, Bioengineering, Cardiovascular, Acute Respiratory Distress Syndrome, Rare Diseases, Clinical Trials and Supportive Activities, Respiratory, Good Health and Well Being, Adult, Aged, Atracurium, Combined Modality Therapy, Conscious Sedation, Female, Hospital Mortality, Humans, Male, Middle Aged, Neuromuscular Blockade, Neuromuscular Blocking Agents, Positive-Pressure Respiration, Respiratory Distress Syndrome, Treatment Failure, National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear.MethodsWe randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of

Published
2019

8. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness

Author

Girard, Timothy D, Exline, Matthew C, Carson, Shannon S, Hough, Catherine L, Rock, Peter, Gong, Michelle N, Douglas, Ivor S, Malhotra, Atul, Owens, Robert L, Feinstein, Daniel J, Khan, Babar, Pisani, Margaret A, Hyzy, Robert C, Schmidt, Gregory A, Schweickert, William D, Hite, R Duncan, Bowton, David L, Masica, Andrew L, Thompson, Jennifer L, Chandrasekhar, Rameela, Pun, Brenda T, Strength, Cayce, Boehm, Leanne M, Jackson, James C, Pandharipande, Pratik P, Brummel, Nathan E, Hughes, Christopher G, Patel, Mayur B, Stollings, Joanna L, Bernard, Gordon R, Dittus, Robert S, and Ely, E Wesley

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Mental Health, Acquired Cognitive Impairment, Brain Disorders, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Antipsychotic Agents, Critical Illness, Delirium, Dopamine Antagonists, Double-Blind Method, Female, Haloperidol, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Piperazines, Respiratory Insufficiency, Shock, Thiazoles, Treatment Failure, MIND-USA Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundThere are conflicting data on the effects of antipsychotic medications on delirium in patients in the intensive care unit (ICU).MethodsIn a randomized, double-blind, placebo-controlled trial, we assigned patients with acute respiratory failure or shock and hypoactive or hyperactive delirium to receive intravenous boluses of haloperidol (maximum dose, 20 mg daily), ziprasidone (maximum dose, 40 mg daily), or placebo. The volume and dose of a trial drug or placebo was halved or doubled at 12-hour intervals on the basis of the presence or absence of delirium, as detected with the use of the Confusion Assessment Method for the ICU, and of side effects of the intervention. The primary end point was the number of days alive without delirium or coma during the 14-day intervention period. Secondary end points included 30-day and 90-day survival, time to freedom from mechanical ventilation, and time to ICU and hospital discharge. Safety end points included extrapyramidal symptoms and excessive sedation.ResultsWritten informed consent was obtained from 1183 patients or their authorized representatives. Delirium developed in 566 patients (48%), of whom 89% had hypoactive delirium and 11% had hyperactive delirium. Of the 566 patients, 184 were randomly assigned to receive placebo, 192 to receive haloperidol, and 190 to receive ziprasidone. The median duration of exposure to a trial drug or placebo was 4 days (interquartile range, 3 to 7). The median number of days alive without delirium or coma was 8.5 (95% confidence interval [CI], 5.6 to 9.9) in the placebo group, 7.9 (95% CI, 4.4 to 9.6) in the haloperidol group, and 8.7 (95% CI, 5.9 to 10.0) in the ziprasidone group (P=0.26 for overall effect across trial groups). The use of haloperidol or ziprasidone, as compared with placebo, had no significant effect on the primary end point (odds ratios, 0.88 [95% CI, 0.64 to 1.21] and 1.04 [95% CI, 0.73 to 1.48], respectively). There were no significant between-group differences with respect to the secondary end points or the frequency of extrapyramidal symptoms.ConclusionsThe use of haloperidol or ziprasidone, as compared with placebo, in patients with acute respiratory failure or shock and hypoactive or hyperactive delirium in the ICU did not significantly alter the duration of delirium. (Funded by the National Institutes of Health and the VA Geriatric Research Education and Clinical Center; MIND-USA ClinicalTrials.gov number, NCT01211522 .).

Published
2018

9. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial

Author

Self, Wesley H., Sandkovsky, Uriel, Reilly, Cavan S., Vock, David M., Gottlieb, Robert L., Mack, Michael, Golden, Kevin, Dishner, Emma, Vekstein, Andrew, Ko, Emily R., Der, Tatyana, Franzone, John, Almasri, Eyad, Fayed, Mohamed, Filbin, Michael R., Hibbert, Kathryn A., Rice, Todd W., Casey, Jonathan D., Hayanga, J. Awori, Badhwar, Vinay, Leshnower, Bradley G., Sharifpour, Milad, Knowlton, Kirk U., Peltan, Ithan D., Bakowska, Elizieta, Kowalska, Justyna, Bowdish, Michael E., Sturek, Jeffrey M., Rogers, Angela J., Files, D. Clark, Mosier, Jarrod M., Gong, Michelle N., Douin, David J., Hite, R. Duncan, Trautner, Barbara W., Jain, Mamta K., Gardner, Edward M., Khan, Akram, Jensen, Jens-Ulrik, Matthay, Michael A., Ginde, Adit A., Brown, Samuel M., Higgs, Elizabeth S., Pett, Sarah, Weintrob, Amy C., Chang, Christina C., Murrary, Daniel D., Günthard, Huldrych F., Moquete, Ellen, Grandits, Greg, Engen, Nicole, Grund, Birgit, Sharma, Shweta, Cao, Huyen, Gupta, Rajesh, Osei, Suzette, Margolis, David, Zhu, Qing, Polizzotto, Mark N., Babiker, Abdel G., Davey, Victoria J., Kan, Virginia, Thompson, B. Taylor, Gelijns, Annetine C., Neaton, James D., Lane, H. Clifford, Jundgren, Jens D., Tierney, John, Barrett, Kevin, Herpin, Betsey R., Smolskis, Mary C., Voge, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Kirchoff, Matthew, Sardana, Ratna, Raim, Sharon Segal, Chiu, Joseph, Hensley, Lisa, Lorenzo, Josua, Mock, Rebecca, Shaw-Saliba, Katy, Zuckerman, Judith, Adam, Stacey J., Currier, Judy, Read, Sarah, Hughes, Eric, Amos, Laura, Carlsen, Amy, Carter, Anita, Davis, Bionca, Denning, Eileen, DuChene, Alain, Harrison, Merrie, Kaiser, Payton, Koopmeiners, Joseph, Meger, Sue, Murray, Thomas, Quan, Kien, Quan, Siu Fun, Thompson, Greg, Walski, Jamie, Wentworth, Deborah, Moskowitz, Alan J., Bagiella, Emilia, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Berhe, Mezgebe, Haley, Clinton, Bettacchi, Christopher, Duhaime, Erin, Ryan, Madison, Burris, Sarah, Jones, Felecia, Villa, Samantha, Want, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Marian, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Lusk, Erica, Killian, Aaron, Palacious, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Smith, Peter K., Barkauskas, Christina E., Dreyer, Grace R., Witte, Marie, Mosaly, Nilima, Mourad, Ahmad, Holland, Thomas L., Lane, Kathleen, Bouffler, Andrew, McGowan, Lauren M., Motta, Marry, Tipton, Gregory, Stallings, Ben, Stout, Gennifer, McLendon-Arvik, Beth, Hollister, Beth A., Giangiacomo, Dana M., Sharma, Sunil, Pappers, Brian, McCarthy, Paul, Krupica, Troy, Sarwari, Arif, Reece, Rebecca, Fornaresio, Lisa, Glaze, Chad, Evans, Raquel, Preamble, Katarina, Sutton, Lisa Giblin, Buterbaugh, Sabrina, Bartolo, Elizabeth Berry, Williams, Roger, Bunner, Robin, Bender, William, Miller, Jeffrey, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Maton, Missy, Ponder, Chari, Haley, Elizabeth, Spainhour, Christine, Rogers, Susan, Tyler, Derrick, Wald-Dickler, Noah, Hutcheon, Douglass, Towfighi, Amytis, Lee, May M., Lewis, Meghan R., Spellberg, Brad, Sher, Linda, Sharma, Aniket, Olds, Anna P., Justino, Chris, Lozano, Edward, Romero, Chris, Leong, Janet, Rodina, Valentina, Possemato, Tammie, Escobar, Jose, Chiu, Charlene, Weissman, Kevin, Barros, Andrew, Enfield, Kyle B., Kadl, Alexandra, Green, China J., Simon, Rachel M., Fox, Ashley, Thornton, Kara, Parrino, Patrick E., Spindel, Stephen, Bansal, Aditya, Baumgarten, Katherine, Hand, Jonathan, Vonderhaar, Derek, Nossaman, Bobby, Laudun, Sylvia, Ames, DeAnna, Broussard, Shane, Hernandez, Nilmo, Isaac, Geralyn, Dinh, Huan, Zheng, Yiling, Tran, Sonny, McDaniel, Hunter, Crovetto, Nicolle, Miller, Leslie, Schelle, Beth, McLean, Sherry, Rothbaum, Howard R., Alvarez, Michael S., Kalan, Shivam P., Germann, Heather H., Hendershot, Jennifer, Maroney, Karen, Herring, Karen, Cook, Sharri, Paul, Pam, Madathil, Ronson J., Rabin, Joseph, Levine, Andrea, Saharia, Kapil, Tabatabai, Ali, Lau, Christine, Gammie, James S., Peguero, Maya-Loren, McKernan, Kimberley, Audette, Matthew, Fleischmann, Emily, Akbari, Freshta, Lee, Maia, Lee, Myounghee, Chi, Andrew, Salehi, Hanna, Pariser, Alan, Nguyen, Phuong Tran, Moore, Jessica, Gee, Adrienne, Vincent, Shelika, Zuckerman, Richard A., Iribarne, Alexander, Metzler, Sara, Shipman, Samantha, Caccia, Taylor, Johnson, Haley, Newton, Crystallee, Parr, Doug, Rodriguez, Vicente, Bokhart, Gordon, Eichman, Sharon M., North, Crystal, Oldmixon, Cathryn, Ringwood, Nancy, Fitzgerald, Laura, Morin, Haley D., Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Aggarwal, Neil R., Bienstock, Karen, Hou, Peter, Steingrub, Jay, Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, DeSouza, Leslie, Thornton-Thompson, Sherell, Talmor, Daniel, Shapiro, Nathan, Banner-Goodspeed, Valerie, Boyle, Katherine L., Hayes, Sharon, Jones, Alan E., Galbraith, James, Nandi, Utsav, Peacock, Rebekah K., Parry, Blair Alden, Margolin, Justin D., Brait, Kelsey, Beakes, Caroline, Kangelaris, Kirsten N., Yee, Kimberly J., Ashktorab, Kimia, Jauregui, Alejandra E., Zhuo, Hanjing, Hendey, Gregory, Hubel, Kinsley A., Hughes, Alyssa R., Garcia, Rebekah L., Wilson, Jennifer G., Vojnik, Rosemary, Roque, Jonasel, Perez, Cynthia, Lim, George W., Chang, Steven Y., Beutler, Rebecca, Agarwal, Trisha, Vargas, Julia, Moss, Marc, Baduashvili, Amiran, Chauhan, Lakshmi, Finck, Lani L., Howell, Michelle, Hyzy, Robert C., Park, Pauline K., Nelson, Kristine, McSparron, Jake I., Co, Ivan N., Wang, Bonnie R., Jia, Shijing, Sullins, Barbara, Hanna, Sinan, Olbrich, Norman, Richardson, Lynne D., Nair, Rahul, Offor, Obiageli, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Terndrup, Thomas E., Wiedemann, Herbert P., Duggal, Abhijit, Thiruchelvam, Nirosshan, Ashok, Kiran, King, Alexander H., Mehkri, Omar, Hudock, Kristin, Kiran, Simra, More, Harshada, Roads, Tammy, Martinkovic, Jamie, Kennedy, Sarah, Robinson, Bryce H., Hough, Catherine L., Krol, Olivia F., Kinjal, Mistry, Mills, Emmanuel, McDougal, Madeline, Deshmukh, Rupali, Chen, Peter, Torbati, Sam S., Matusov, Yuri, Choe, June, Hindoyan, Niree A., Jackman, Susan E., Bayoumi, Emad, Wynter, Timothy, Caudill, Antonina, Pascual, Ethan, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Mehdikhani, Shaunt, O'Mahony, D. Shane, Nyatsatsang, Sonam T., Wilson, David M., Wallick, Julie A., Miller, Chadwick, Gibbs, Keven W., Flores, Lori S., LaRose, Mary E., Landreth, Leigha D., Morris, Peter E., Sturgill, Jamie L., Cassity, Evan P., Dhar, Sanjay, Montgomery-Yates, Ashley A., Pasha, Sara N., Mayer, Kirby P., Bissel, Brittany, Bledsoe, Joseph, Brown, Samuel, Lanspa, Michael, Leither, Lindsey, Armbruster, Brent P., Montgomery, Quinn, Applegate, Darrin, Kumar, Naresh, Fergus, Melissa, Serezlic, Erna, Imel, Karah, Palmer, Ghazal, Webb, Brandon, Aston, Valerie T., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Sánchez, Adriana, Popielski, Laura, Rivasplata, Heather, Turner, Melissa, Vjecha, Michael, Petersen, Tianna, Kamel, Dena, Hansen, Laura, Lucas, Claudia Sanchez, DellaValle, Natalie, Gonzales, Sonia, Scott, James, Wyles, David, Douglas, Ivor, Haukoos, Jason, Kamis, Kevin, Robinson, Caitlin, Baker, Jason V., Frosch, Anne, Goldsmith, Rachael, Jibrell, Hodan, Lo, Melanie, Klaphake, Jonathan, Mackedanz, Shari, Ngo, Linh, Garcia-Myers, Kelly, Markowitz, Norman, Pastor, Erika, Ramesh, Mayur, Brar, Indira, Rivers, Emanuel, Kumar, Princy, Menna, Maximiliano, Biswas, Kousick, Harrington, Cristin, Delp, Alex, Pandit, Lavannya, Hines-Munson, Casey, Van, John, Dillon, Laura, Want, Yiqun, Lichtenberger, Paola, Baracco, Gio, Ramos, Carol, Bjork, Lauren, Sueiro, Melyssa, Tien, Phyllis, Freasier, Heather, Buck, Theresa, Nekach, Hafida, Nagy-Agren, Stephanie, Vasudeva, Shikha, Ochalek, Tracy, Roller, Brentin, Nguyen, Chinh, Mikail, Amani, Raben, Dorthe, Jensen, Tomas O., Aagaard, Bitten, Nielsen, Charlotte B., Krapp, Katharina, Nykjær, Bente Rosdahl, Kanne, Katja Lisa, Grevsen, Anne Louise, Joensen, Zillah Maria, Bruun, Tina, Bojesen, Ane, Woldbye, Frederik, Normand, Nick E., Esmann, Frederik V.L., Clausen, Clara Lundetoft, Hovmand, Nichlas, Pedersen, Karen Brorup, Thorlacius-Ussing, Louise, Tinggaard, Michaela, Høgsberg, Dorthe S., Rastoder, Ema, Kamstrup, Thobias, Bergsøe, Christina Marisa, Østergaard, Lars, Stærke, Nina Breinholt, Johansen, Isik S., Knudtzen, Fredrikke C., Larsen, Lykke, Hertz, Mathias A., Fabricius, Thilde, Helleberg, Marie, Gerstoft, Jan, Jensen, Tomas Østergaard, Lindegaard, Birgitte, Pedersen, Thomas Ingemann, Røge, Birgit Thorup, Løfberg, Sandra Valborg, Hansen, Thomas Michael, Nielsen, Ariella Denize, von Huth, Sebastian Leicht, Nielsen, Henrik, Thisted, Rikke Krog, Podlekareva, Daria, Johnsen, Stine, Andreassen, Helle Frost, Pedersen, Lars, Lindnér, Cecilia Ebba Clara Ellinor, Wiese, Lothar, Knudsen, Lene Surland, Nytofte, Nikolaj Julian Skrøder, Havmøller, Signe Ravn, Paredes, Roger, Exposito, Maria, Fernández-Cruz, Eduardo, Muñoz, José, Arribas, Jose R., Estrada, Vicente, Horcajada, Juan P., Burgos, Joaquin, Morales-Rull, Jose Luis, Braun, Dominique L., West, Emily, M'Rabeth-Bensalah, Khadija, Eichinger, Mareile L., Grüttner-Durmaz, Manuela, Grube, Christina, Zink, Veronika, Horban, Andrzej, Bednarska, Agnieszka, Jurek, Natalia, Fätkenheuer, Gerd, Malinm, Jakob J., Matthews, Gail, Kelleher, Anthony, Cabrera, Gesalit, Carey, Catherine, Hough, Sally, Virachit, Sophie, Zhong, Amy, Young, Barnaby E., Chia, Po Ying, Lee, Tau Hong, Lin, Ray J., Lye, David, Ong, Sean, Puah, Ser Hon, Yeo, Tsin Wen, Diong, Shiau Hui, Ongko, Juwinda, Hudson, Fleur, Parmar, Mahesh KB, Goodman, Anna, Badrock, Jonathan, Gregory, Adam, Harris, Nicola, Touloumi, Giota, Pantaz, Nikos, Gioukari, Vicky, Lutaakome, Joseph, Kityo, Cissy M., Mugerwa, Henry, Kiweewa, Francis, Osinusi, Anu, Tipple, Craig, Willis, Angela, Peppercorn, Amanda, Watson, Helen, Alexander, Elizabeth, Mogalian, Erik, Lin, Leo, Ding, Xiao, Yan, Li, Girardet, Jean-Luc, Ma, Ji, Hong, Zhi, Adams, Amy, Albert, Sara, Balde, Abby, Baracz, Michelle, Baseler, Beth, Becker, Nancy, Bielica, Mona, Billouin-Frazier, Shere, Cash, Jennifer, Choudhary, Jay, Dolney, Suzanne, Dixon, Mary, Eyler, Carolyn, Frye, Leanna, Galcik, Michael, Gertz, Jensen, Giebeig, Lisa, Gulati, Neelam, Hankinson, Liz, Hissey, Debbie, Hogarty, Debi, Hohn, Matt, Holley, H Preston, Hoopengardner, Lisa, Huber, Lynda, Jankelevich, Shirley, Krauss, Gary, Lake, Eileen, Linton, Jessica, MacDonald, Leah, Manandhar, Meryan, Spinelli-Nadzam, Mary, Oluremi, Charles, Proffitt, Calvin, Rudzinski, Erin, Sandrus, Jen, Schaffhauser, Marylu, Schechner, Adam, Suders, Connie, Gerry, Norman P., Smith, Kenneth, Solomon, Courtney, Kubernac, Amanda, Rashid, Marium, Patel, Bhakti, Kubernac, Robert, Murphy, Joseph, Hoover, Marie L., Brown, Craig, DuChateau, Nadine, Flosi, Adam, Johnson, Les, Treagus, Amy, and Wenner, Christine

Published
2022
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10. Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome.

Author

Huang, David T, Angus, Derek C, Moss, Marc, Thompson, B Taylor, Ferguson, Niall D, Ginde, Adit, Gong, Michelle Ng, Gundel, Stephanie, Hayden, Douglas L, Hite, R Duncan, Hou, Peter C, Hough, Catherine L, Iwashyna, Theodore J, Liu, Kathleen D, Talmor, Daniel S, Yealy, Donald M, and Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators

Subjects
Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators, Humans, Respiratory Distress Syndrome, Adult, Atracurium, Neuromuscular Blocking Agents, Respiration, Artificial, Positive-Pressure Respiration, Neuromuscular Blockade, Mortality, Cause of Death, Feasibility Studies, Mental Recall, Muscle Strength, adult, clinical trial, interdisciplinary communication, methods, respiratory distress syndrome, Respiratory Distress Syndrome, Rare Diseases, Clinical Research, Patient Safety, Prevention, Clinical Trials and Supportive Activities, Lung, Acute Respiratory Distress Syndrome, Respiratory
Abstract

The Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) trial is a multicenter, randomized trial designed to assess the efficacy and safety of early neuromuscular blockade in patients with moderate to severe acute respiratory distress syndrome. This document provides background for interpretation of the trial results, and highlights unique design approaches that may inform future trials of acute illness. We describe the process by which ROSE was chosen as the inaugural trial of the multidisciplinary Prevention and Early Treatment of Acute Lung Injury Network, provide the trial methodology using the Consolidated Standards of Reporting Trials framework, and discuss key design challenges and their resolution. Four key design issues proved challenging-feasibility, choice of sedation depth in the control group, impact of emphasizing early treatment on enrollment criteria and protocol execution, and choice of positive end-expiratory pressure strategy. We used literature, an iterative consensus model, and internal surveys of current practice to inform design choice. ROSE will provide definitive, Consolidated Standards of Reporting Trials adherent data on early neuromuscular blockade for future patients with acute respiratory distress syndrome. Our multidisciplinary approach to trial design may be of use to other trials of acute illness. Clinical trial registered with www.clinicaltrials.gov (NCT02509078).

Published
2017

11. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Brown, Samuel M, primary, Barkauskas, Christina E, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Phillips, Andrew N, additional, Leither, Lindsay, additional, Peltan, Ithan D, additional, Lanspa, Michael, additional, Gilstrap, Daniel L, additional, Mourad, Ahmad, additional, Lane, Kathleen, additional, Beitler, Jeremy R, additional, Serra, Alexis L, additional, Garcia, Ivan, additional, Almasri, Eyad, additional, Fayed, Mohamed, additional, Hubel, Kinsley, additional, Harris, Estelle S, additional, Middleton, Elizabeth A, additional, Barrios, Macy A G, additional, Mathews, Kusum S, additional, Goel, Neha N, additional, Acquah, Samuel, additional, Mosier, Jarrod, additional, Hypes, Cameron, additional, Salvagio Campbell, Elizabeth, additional, Khan, Akram, additional, Hough, Catherine L, additional, Wilson, Jennifer G, additional, Levitt, Joseph E, additional, Duggal, Abhijit, additional, Dugar, Siddharth, additional, Goodwin, Andrew J, additional, Terry, Charles, additional, Chen, Peter, additional, Torbati, Sam, additional, Iyer, Nithya, additional, Sandkovsky, Uriel S, additional, Johnson, Nicholas J, additional, Robinson, Bryce R H, additional, Matthay, Michael A, additional, Aggarwal, Neil R, additional, Douglas, Ivor S, additional, Casey, Jonathan D, additional, Hache-Marliere, Manuel, additional, Georges Youssef, J, additional, Nkemdirim, William, additional, Leshnower, Brad, additional, Awan, Omar, additional, Pannu, Sonal, additional, O'Mahony, Darragh Shane, additional, Manian, Prasad, additional, Awori Hayanga, J W, additional, Wortmann, Glenn W, additional, Tomazini, Bruno M, additional, Miller, Robert F, additional, Jensen, Jens-Ulrik, additional, Murray, Daniel D, additional, Bickell, Nina A, additional, Zatakia, Jigna, additional, Burris, Sarah, additional, Higgs, Elizabeth S, additional, Natarajan, Ven, additional, Dewar, Robin L, additional, Schechner, Adam, additional, Kang, Nayon, additional, Arenas-Pinto, Alejandro, additional, Hudson, Fleur, additional, Ginde, Adit A, additional, Self, Wesley H, additional, Rogers, Angela J, additional, Oldmixon, Cathryn F, additional, Morin, Haley, additional, Sanchez, Adriana, additional, Weintrob, Amy C, additional, Cavalcanti, Alexandre Biasi, additional, Davis-Karim, Anne, additional, Engen, Nicole, additional, Denning, Eileen, additional, Taylor Thompson, B, additional, Gelijns, Annetine C, additional, Kan, Virginia, additional, Davey, Victoria J, additional, Lundgren, Jens D, additional, Babiker, Abdel G, additional, Neaton, James D, additional, Lane, H Clifford, additional, Tierney, John, additional, Vogel, Susan E., additional, McNay, Laura A., additional, Cahill, Kelly, additional, Crew, Page, additional, Sardana, Ratna, additional, Segal Raim, Sharo, additional, Shaw-Saliba, Katy, additional, Atri, Negin, additional, Miller, Mark, additional, Vallee, David, additional, Chung, Lucy, additional, Delph, Yvette, additional, Adam, Stacey J., additional, Read, Sarah, additional, Draghia-Akli, Ruxandra, additional, Harrigan, Rachel, additional, Carlsen, Amy, additional, Carter, Anita, additional, DuChene, Alain, additional, Eckroth, Kate, additional, Frase, Alex, additional, Harrison, Merrie, additional, Meger, Sue, additional, Quan, Kien, additional, Quan, Siu Fun, additional, Reilly, Cavan, additional, Thompson, Greg, additional, Walski, Jamie, additional, Moskowitz, Alan J., additional, Bagiella, Emilia, additional, Moquete, Ellen, additional, O'Sullivan, Karen, additional, Marks, Mary E., additional, Accardi, Evan, additional, Kinzel, Emily, additional, Bedoya, Gabriela, additional, Gupta, Lopa, additional, Overbey, Jessica R., additional, Padillia, Maria L., additional, Santos, Milerva, additional, Gillinov, Marc A., additional, Miller, Marissa A., additional, Taddei-Peters, Wendy C., additional, Fenton, Kathleen, additional, Smith, Peter K., additional, Vekstein, Andrew M., additional, Ko, Emily R., additional, Al-Hegelan, Mashael S., additional, McGowan, Lauren M., additional, Motta, Mary, additional, Howell, Shauna, additional, Bent, Francine, additional, Kalager, Rachel, additional, Chan, Emmanuel, additional, Aloor, Heather L., additional, Griffin, S. Michelle, additional, Covington, Anna, additional, McLendon-Arvik, Beth, additional, Bussadori, Barbara, additional, Miller-Bell, Mary, additional, Sampey, Cathy, additional, Gaver, Vincent, additional, Hollister, Beth A., additional, Giangiacomo, Dana M., additional, Pauley, Alena, additional, Patel, Aashay, additional, Classon, Chris, additional, Frazier, Madison, additional, Osborne, Robyn, additional, Conlon, Debbi H., additional, Joshi, Marybeth, additional, Gottlieb, Robert L., additional, Mack, Michael, additional, Berhe, Mezgebe, additional, Haley, Clinton, additional, Dishner, Emma, additional, Bettacchi, Christopher, additional, Golden, Kevin, additional, Duhaime, Erin, additional, Ryan, Madison, additional, Tallmadge, Catherine, additional, Estrada, Lorie, additional, Jones, Felecia, additional, Villa, Samantha, additional, Wang, Samantha, additional, Robert, Raven, additional, Coleman, Tanquinisha, additional, Clariday, Laura, additional, Baker, Rebecca, additional, Hurutado-Rodriguez, Mariana, additional, Iram, Nazia, additional, Fresnedo, Michelle, additional, Davis, Allyson, additional, Leonard, Kiara, additional, Ramierez, Noelia, additional, Thammavong, Jon, additional, Duque, Krizia, additional, Turner, Emma, additional, Fisher, Tammy, additional, Robinson, Dianna, additional, Ransom, Desirae, additional, Maldonado, Nicholas, additional, Lusk, Erica, additional, Killian, Aaron, additional, Palacios, Adriana, additional, Solis, Edilia, additional, Jerrow, Janet, additional, Watts, Matthew, additional, Whitacre, Heather, additional, Cothran, Elizabeth, additional, Bender, William, additional, Miller, Jeffrey, additional, Nugent, Katherine, additional, Farrington, Woodrow, additional, Baio, Kim T., additional, McBride, Mary K., additional, Fielding, Michele, additional, Mathewson, Sonya, additional, Porte, Kristina, additional, Haley, Elizabeth, additional, Rogers, Susan, additional, Tyler, Derrick, additional, Perin, Emerson, additional, Costello, Briana, additional, Postalian, Alexander, additional, Sohail, Rizwan, additional, Hinsu, Punit, additional, Watson, Carolyn, additional, Kappenman, Casey, additional, Chen, James, additional, Walker, Kim, additional, Fink, Melyssa, additional, Phillip, Gabrielle, additional, Mahon, Kim, additional, Sturgis, Lydia, additional, Maher, Patrick, additional, Rogers, Linda, additional, Ng, Nicole, additional, Marshall, Jason, additional, Bassily-Marcus, Adel, additional, Cohen, Ivy, additional, Ramoo, Shamini, additional, Malhotra, Aryan, additional, Kessler, Jonathan, additional, Goetz, Rebekah, additional, Badhwar, Vinay, additional, Hayanga, Jeremiah, additional, Giblin Sutton, Lisa, additional, Williams, Roger, additional, Berry Bartolo, Elizabeth, additional, Walker, Dmitry, additional, Bunner, Robin, additional, Glaze, Chad, additional, Aucremanne, Tanja, additional, Bishop, James, additional, Kelley, Macey, additional, Peterson, Autumn, additional, Sauerborn, Erica, additional, Reckart, Robin, additional, Miller, Brittany, additional, Mittel, Aaron, additional, Darmanian, Anita, additional, Rosen, Amanda, additional, Madahar, Purnema, additional, Schicchi, John, additional, Gosek, Katarzyna, additional, Dzierba, Amy, additional, Wahab, Romina, additional, Eng, Connie, additional, Al-Saadi, Mukhtar, additional, Zahiruddin, Faisal, additional, Syed, Mohi, additional, George, Michael, additional, Patel, Varsha, additional, Onwunyi, Chisom, additional, Barroso da Costa, Rosa, additional, North, Crystal, additional, Ringwood, Nancy, additional, Fitzgerald, Laura, additional, Muzikansky, Ariela, additional, Morse, Richard, additional, Brower, Roy G., additional, Reineck, Lora A., additional, Bienstock, Karen, additional, Hou, Peter, additional, Steingrub, Jay S., additional, Tidswell, Mark A., additional, Kozikowski, Lori-Ann, additional, Kardos, Cynthia, additional, De Souza, Leslie, additional, Talmor, Daniel, additional, Shapiro, Nathan, additional, Hibbert, Kathryn, additional, Brait, Kelsey, additional, Kone, Mamary, additional, Hendey, Gregory, additional, Kangelaris, Kirsten N., additional, Ashktorab, Kimia, additional, Gropper, Rachel, additional, Agrawal, Anika, additional, Timothy, Kelly, additional, Zhou, Hanjing, additional, Hughes, Alyssa, additional, Garcia, Rebekah, additional, Torres, Adrian, additional, Hernandez-Almaraz, Maria Elena, additional, Vojnik, Rosemary, additional, Perez, Cynthia, additional, McDowell, Jordan, additional, Chang, Steven Y., additional, Vargas, Julia, additional, Moss, Marc, additional, McKeehan, Jeffrey, additional, Higgins, Carrie, additional, Johnson, Emily, additional, Slaughter, Suzanne, additional, Wyles, David, additional, Hiller, Terra, additional, Oakes, Judy, additional, Garcia, Ana, additional, Gravitz, Stephanie, additional, Lyle, Carolynn, additional, Swanson, Diandra, additional, Gong, Michelle Ng., additional, Richardson, Lynnne D., additional, Chen, Jen-Ting, additional, Moskowitz, Ari, additional, Mohamed, Amira, additional, Lopez, Brenda, additional, Amosu, Omowunmi, additional, Tzehaie, Hiwet, additional, Boujid, Sabah, additional, Bixby, Billie, additional, Lopez, Anitza A., additional, Durley, JaVon, additional, Gilson, Boris, additional, Hite, R. Duncan, additional, Wang, Henry, additional, Wiedemann, Hebert P., additional, Mehkri, Omar, additional, Ashok, Kiran, additional, King, Alexander, additional, Brennan, Connery, additional, Exline, Matthew C., additional, Englert, Joshua A., additional, Karow, Sarah, additional, Schwartz, Elizabeth, additional, So, Preston, additional, So, Madison, additional, Krol, Olivia F., additional, Briceno Parra, Genesis I., additional, Mills, Emmanuel Nii Lantei, additional, Oh, Minn, additional, Pena, Jose, additional, Martínez, Jesús Alejandro, additional, Jackman, Susan E., additional, Bayoumi, Emad, additional, Pascual, Ethan, additional, Caudill, Antonina, additional, Chen, Po-En, additional, Richardson, Tabia, additional, Clapham, Gregg J., additional, Herrera, Lisa, additional, Ojukwu, Cristabelle, additional, Fine, Devin, additional, Gomez, Millie J., additional, Choi-Kuaea, Yunhee, additional, Weissberg, Gwendolyn, additional, Isip, Katherine, additional, Mattison, Brittany, additional, Tran, Dana, additional, Emilov Dukov, Jennifer, additional, Chung, Paul, additional, Kang, Bo Ran, additional, Escobar, Lauren, additional, Tran, Trung, additional, Baig, Saba, additional, Wallick, Julie A., additional, Duven, Alexandria M., additional, Fletcher, Dakota D., additional, Gundel, Stephanie, additional, Fuentes, Megan, additional, Newton, Maranda, additional, Peterson, Emily, additional, Jiang, Kelsey, additional, Files, D. Clark, additional, Miller, Chadwick, additional, Lematty, Caitlin, additional, Rasberry, April, additional, Warden, Ashley, additional, Bledsoe, Joseph, additional, Knowlton, Kirk, additional, Knox, Daniel B., additional, Klippel, Carolyn, additional, Armbruster, Brent P., additional, Applegate, Darrin, additional, Imel, Karah, additional, Fergus, Melissa, additional, Rahmati, Kasra, additional, Jensen, Hannah, additional, Aston, Valerie T., additional, Jeppson, Joshua, additional, Marshall, J. Hunter, additional, Lumpkin, Jenna, additional, Smith, Cassie, additional, Burke, Tyler, additional, Gray, Andrew, additional, Paine, Robert, additional, Callahan, Sean, additional, Yamane, Misty, additional, Waddoups, Lindsey, additional, Rice, Todd W., additional, Johnson, Jakea, additional, Gray, Christopher, additional, Hays, Margaret, additional, Roth, Megan, additional, Musick, Sarah, additional, Miller, Karen, additional, Semler, Matthew W., additional, Popielski, Laura, additional, Kambo, Amy, additional, Viens, Kimberly, additional, Turner, Melissa, additional, Vjecha, Michael J., additional, Denyer, Rachel, additional, Khosla, Rahul, additional, Rajendran, Bindu, additional, Gonzales, Melissa, additional, Moriarty, Theresa, additional, Biswas, Kousick, additional, Harrington, Cristin, additional, Garcia, Amanda, additional, Bremer, Tammy, additional, Burke, Tara, additional, Koker, Brittany, additional, Pittman, David, additional, Vasudeva, Shikha S., additional, Anholm, James D., additional, Specht, Lennard, additional, Rodriguez, Aimee, additional, Ngo, Han, additional, Duong, Lien, additional, Previte, Matthew, additional, Raben, Dorthe, additional, Nielsen, Charlotte B., additional, Friis Larsen, Jakob, additional, Peters, Lars, additional, Matthews, Gail, additional, Kelleher, Anthony, additional, Polizzotto, Mark, additional, Carey, Catherine, additional, Chang, Christina, additional, Dharan, Nila, additional, Hough, Sally, additional, Virachit, Sophie, additional, Davidson, Sarah, additional, Bice, Daniel J., additional, Ognenovska, Katherine, additional, Cabrera, Gesalit, additional, Flynn, Ruth, additional, Abdelghany, Mazin, additional, Baseler, Beth, additional, Teitelbaum, Marc, additional, Holley, H. Preston, additional, Jankelevich, Shirley, additional, Adams, Amy, additional, Becker, Nancy, additional, Doleny, Suzanne, additional, Hissey, Debbie, additional, Simpson, Shelly, additional, Kim, Mi Ha, additional, Beeler, Joy, additional, Harmon, Liam, additional, Vanderpuye, Sharon, additional, Yeon, Lindsey, additional, Frye, Leanna, additional, Rudzinski, Erin, additional, Buehn, Molly, additional, Eccard-Koons, Vanessa, additional, Frary, Sadie, additional, MacDonalad, Leah, additional, Cash, Jennifer, additional, Hoopengardner, Lisa, additional, Linton, Jessica, additional, Nelson, Michaela, additional, Spinelli-Nadzam, Mary, additional, Proffitt, Calvin, additional, Lee, Christopher, additional, Engel, Theresa, additional, Fontaine, Laura, additional, Osborne, CK, additional, Hohn, Matt, additional, Galcik, Michael, additional, Thompson, DeeDee, additional, Sandrus, Jen, additional, Manchard, Jon, additional, Giri, Jiwan, additional, Kopka, Stacy, additional, Chang, Weizhong, additional, Sherman, Brad T., additional, Rupert, Adam W., additional, Highbarger, Helene, additional, Baseler, Michael, additional, Lallemand, Perrine, additional, Rehman, Tauseef, additional, Imamichi, Tom, additional, Laverdure, Sylvain, additional, Paudel, Sharada, additional, Cook, Kyndal, additional, Haupt, Kendra, additional, Hazen, Allison, additional, Badralmaa, Yunden, additional, Highbarger, Jeroen, additional, McCormack, Ashley, additional, Gerry, Norman P., additional, Smith, Kenneth, additional, Patel, Bhakti, additional, Domeraski, Nadia, additional, Hoover, Marie L., additional, DuChateau, Nadine, additional, Flosi, Adam, additional, Nelson, Rich, additional, Stojanovic, Jelena, additional, and Wenner, Christine, additional

Published
2023
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13. Fluid management with a simplified conservative protocol for the acute respiratory distress syndrome*.

Author

Grissom, Colin K, Hirshberg, Eliotte L, Dickerson, Justin B, Brown, Samuel M, Lanspa, Michael J, Liu, Kathleen D, Schoenfeld, David, Tidswell, Mark, Hite, R Duncan, Rock, Peter, Miller, Russell R, Morris, Alan H, and National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network

Subjects
National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network, Humans, Shock, Furosemide, Diuretics, Clinical Protocols, Fluid Therapy, Respiration, Artificial, Retrospective Studies, Random Allocation, Water-Electrolyte Balance, Central Venous Pressure, Middle Aged, Intensive Care Units, United States, Female, Male, Respiratory Distress Syndrome, Clinical Trials and Supportive Activities, Clinical Research, acute kidney injury, adult respiratory distress syndrome, clinical protocols, critical illness, fluid therapy, shock, Clinical Sciences, Nursing, Public Health and Health Services, Emergency & Critical Care Medicine
Abstract

ObjectivesIn the Fluid and Catheter Treatment Trial (FACTT) of the National Institutes of Health Acute Respiratory Distress Syndrome Network, a conservative fluid protocol (FACTT Conservative) resulted in a lower cumulative fluid balance and better outcomes than a liberal fluid protocol (FACTT Liberal). Subsequent Acute Respiratory Distress Syndrome Network studies used a simplified conservative fluid protocol (FACTT Lite). The objective of this study was to compare the performance of FACTT Lite, FACTT Conservative, and FACTT Liberal protocols.DesignRetrospective comparison of FACTT Lite, FACTT Conservative, and FACTT Liberal. Primary outcome was cumulative fluid balance over 7 days. Secondary outcomes were 60-day adjusted mortality and ventilator-free days through day 28. Safety outcomes were prevalence of acute kidney injury and new shock.SettingICUs of Acute Respiratory Distress Syndrome Network participating hospitals.PatientsFive hundred three subjects managed with FACTT Conservative, 497 subjects managed with FACTT Liberal, and 1,124 subjects managed with FACTT Lite.InterventionsFluid management by protocol.Measurements and main resultsCumulative fluid balance was 1,918 ± 323 mL in FACTT Lite, -136 ± 491 mL in FACTT Conservative, and 6,992 ± 502 mL in FACTT Liberal (p < 0.001). Mortality was not different between groups (24% in FACTT Lite, 25% in FACTT Conservative and Liberal, p = 0.84). Ventilator-free days in FACTT Lite (14.9 ± 0.3) were equivalent to FACTT Conservative (14.6 ± 0.5) (p = 0.61) and greater than in FACTT Liberal (12.1 ± 0.5, p < 0.001 vs Lite). Acute kidney injury prevalence was 58% in FACTT Lite and 57% in FACTT Conservative (p = 0.72). Prevalence of new shock in FACTT Lite (9%) was lower than in FACTT Conservative (13%) (p = 0.007 vs Lite) and similar to FACTT Liberal (11%) (p = 0.18 vs Lite).ConclusionsFACTT Lite had a greater cumulative fluid balance than FACTT Conservative but had equivalent clinical and safety outcomes. FACTT Lite is an alternative to FACTT Conservative for fluid management in Acute Respiratory Distress Syndrome.

Published
2015

14. Rosuvastatin for Sepsis-Associated Acute Respiratory Distress Syndrome

Author

Truwit, Jonathon D, Bernard, Gordon R, Steingrub, Jay, Matthay, Michael A, Liu, Kathleen D, Albertson, Timothy E, Brower, Roy G, Shanholtz, Carl, Rock, Peter, Douglas, Ivor S, deBoisblanc, Bennett P, Hough, Catherine L, Hite, R Duncan, and Thompson, B Taylor

Subjects
Sepsis, Lung, Acute Respiratory Distress Syndrome, Clinical Trials and Supportive Activities, Patient Safety, Infectious Diseases, Rare Diseases, Hematology, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Inflammatory and immune system, Respiratory, Infection, Good Health and Well Being, Adult, Aged, Creatine Kinase, Double-Blind Method, Female, Fluorobenzenes, Hospital Mortality, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Liver Failure, Male, Middle Aged, Pyrimidines, Renal Insufficiency, Respiratory Distress Syndrome, Rosuvastatin Calcium, Sulfonamides, Survival Analysis, Treatment Failure, National Heart, Lung, and Blood Institute ARDS Clinical Trials Network, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundIn the acute respiratory distress syndrome (ARDS), inflammation in the lungs and other organs can cause life-threatening organ failure. Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase (statins) can modulate inflammatory responses. Previous observational studies suggested that statins improved clinical outcomes in patients with sepsis. We hypothesized that rosuvastatin therapy would improve clinical outcomes in critically ill patients with sepsis-associated ARDS.MethodsWe conducted a multicenter trial in which patients with sepsis-associated ARDS were randomly assigned to receive either enteral rosuvastatin or placebo in a double-blind manner. The primary outcome was mortality before hospital discharge home or until study day 60 if the patient was still in a health care facility. Secondary outcomes included the number of ventilator-free days (days that patients were alive and breathing spontaneously) to day 28 and organ-failure-free days to day 14.ResultsThe study was stopped because of futility after 745 of an estimated 1000 patients had been enrolled. There was no significant difference between study groups in 60-day in-hospital mortality (28.5% with rosuvastatin and 24.9% with placebo, P=0.21) or in mean (±SD) ventilator-free days (15.1±10.8 with rosuvastatin and 15.1±11.0 with placebo, P=0.96). The groups were well matched with respect to demographic and key physiological variables. Rosuvastatin therapy, as compared with placebo, was associated with fewer days free of renal failure to day 14 (10.1±5.3 vs. 11.0±4.7, P=0.01) and fewer days free of hepatic failure to day 14 (10.8±5.0 vs. 11.8±4.3, P=0.003). Rosuvastatin was not associated with an increased incidence of serum creatine kinase levels that were more than 10 times the upper limit of the normal range.ConclusionsRosuvastatin therapy did not improve clinical outcomes in patients with sepsis-associated ARDS and may have contributed to hepatic and renal organ dysfunction. (Funded by the National Heart, Lung, and Blood Institute and the Investigator-Sponsored Study Program of AstraZeneca; ClinicalTrials.gov number, NCT00979121.).

Published
2014

15. Rosuvastatin for sepsis-associated acute respiratory distress syndrome.

Author

National Heart, Lung, and Blood Institute ARDS Clinical Trials Network, Truwit, Jonathon D, Bernard, Gordon R, Steingrub, Jay, Matthay, Michael A, Liu, Kathleen D, Albertson, Timothy E, Brower, Roy G, Shanholtz, Carl, Rock, Peter, Douglas, Ivor S, deBoisblanc, Bennett P, Hough, Catherine L, Hite, R Duncan, and Thompson, B Taylor

Subjects
National Heart, Lung, and Blood Institute ARDS Clinical Trials Network, Humans, Sepsis, Liver Failure, Respiratory Distress Syndrome, Adult, Sulfonamides, Fluorobenzenes, Pyrimidines, Creatine Kinase, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Treatment Failure, Hospital Mortality, Survival Analysis, Double-Blind Method, Adult, Aged, Middle Aged, Female, Male, Renal Insufficiency, Rosuvastatin Calcium, Respiratory Distress Syndrome, National Heart, Lung, and Blood Institute ARDS Clinical Trials Network, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundIn the acute respiratory distress syndrome (ARDS), inflammation in the lungs and other organs can cause life-threatening organ failure. Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase (statins) can modulate inflammatory responses. Previous observational studies suggested that statins improved clinical outcomes in patients with sepsis. We hypothesized that rosuvastatin therapy would improve clinical outcomes in critically ill patients with sepsis-associated ARDS.MethodsWe conducted a multicenter trial in which patients with sepsis-associated ARDS were randomly assigned to receive either enteral rosuvastatin or placebo in a double-blind manner. The primary outcome was mortality before hospital discharge home or until study day 60 if the patient was still in a health care facility. Secondary outcomes included the number of ventilator-free days (days that patients were alive and breathing spontaneously) to day 28 and organ-failure-free days to day 14.ResultsThe study was stopped because of futility after 745 of an estimated 1000 patients had been enrolled. There was no significant difference between study groups in 60-day in-hospital mortality (28.5% with rosuvastatin and 24.9% with placebo, P=0.21) or in mean (±SD) ventilator-free days (15.1±10.8 with rosuvastatin and 15.1±11.0 with placebo, P=0.96). The groups were well matched with respect to demographic and key physiological variables. Rosuvastatin therapy, as compared with placebo, was associated with fewer days free of renal failure to day 14 (10.1±5.3 vs. 11.0±4.7, P=0.01) and fewer days free of hepatic failure to day 14 (10.8±5.0 vs. 11.8±4.3, P=0.003). Rosuvastatin was not associated with an increased incidence of serum creatine kinase levels that were more than 10 times the upper limit of the normal range.ConclusionsRosuvastatin therapy did not improve clinical outcomes in patients with sepsis-associated ARDS and may have contributed to hepatic and renal organ dysfunction. (Funded by the National Heart, Lung, and Blood Institute and the Investigator-Sponsored Study Program of AstraZeneca; ClinicalTrials.gov number, NCT00979121.).

Published
2014

16. Vascular pedicle width in acute lung injury: correlation with intravascular pressures and ability to discriminate fluid status

Author

Rice, Todd W, Ware, Lorraine B, Haponik, Edward F, Chiles, Caroline, Wheeler, Arthur P, Bernard, Gordon R, Steingrub, Jay S, Hite, R Duncan, Matthay, Michael A, Wright, Patrick, and Ely, E Wesley

Abstract

Abstract Introduction Conservative fluid management in patients with acute lung injury (ALI) increases time alive and free from mechanical ventilation. Vascular pedicle width (VPW) is a non-invasive measurement of intravascular volume status. The VPW was studied in ALI patients to determine the correlation between VPW and intravascular pressure measurements and whether VPW could predict fluid status. Methods This retrospective cohort study involved 152 patients with ALI enrolled in the Fluid and Catheter Treatment Trial (FACTT) from five NHLBI ARDS (Acute Respiratory Distress Syndrome) Network sites. VPW and central venous pressure (CVP) or pulmonary artery occlusion pressure (PAOP) from the first four study days were correlated. The relationships between VPW, positive end-expiratory pressure (PEEP), cumulative fluid balance, and PAOP were also evaluated. Receiver operator characteristic (ROC) curves were used to determine the ability of VPW to detect PAOP

Published
2011

18. Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial

Author

Holland, Thomas L., primary, Ginde, Adit A., additional, Paredes, Roger, additional, Murray, Thomas A., additional, Engen, Nicole, additional, Grandits, Greg, additional, Vekstein, Andrew, additional, Ivey, Noel, additional, Mourad, Ahmad, additional, Sandkovsky, Uriel, additional, Gottlieb, Robert L., additional, Berhe, Mezgebe, additional, Jain, Mamta K., additional, Marines-Price, Rubria, additional, Agbor Agbor, Barbine Tchamba, additional, Mateu, Lourdes, additional, España-Cueto, Sergio, additional, Lladós, Gemma, additional, Mylonakis, Eleftherios, additional, Rogers, Ralph, additional, Shehadeh, Fadi, additional, Filbin, Michael R., additional, Hibbert, Kathryn A., additional, Kim, Kami, additional, Tran, Thanh, additional, Morris, Peter E., additional, Cassity, Evan P., additional, Trautner, Barbara, additional, Pandit, Lavannya M., additional, Knowlton, Kirk U., additional, Leither, Lindsay, additional, Matthay, Michael A., additional, Rogers, Angela J., additional, Drake, Wonder, additional, Jones, Beatrice, additional, Poulakou, Garyfallia, additional, Syrigos, Konstantinos N., additional, Fernández-Cruz, Eduardo, additional, Di Natale, Marisa, additional, Almasri, Eyad, additional, Balerdi-Sarasola, Leire, additional, Bhagani, Sanjay R., additional, Boyle, Katherine L., additional, Casey, Jonathan D., additional, Chen, Peter, additional, Douin, David J., additional, Files, D. Clark, additional, Günthard, Huldrych F., additional, Hite, R. Duncan, additional, Hyzy, Robert C., additional, Khan, Akram, additional, Kibirige, Moses, additional, Kidega, Robert, additional, Kimuli, Ivan, additional, Kiweewa, Francis, additional, Jensen, Jens-Ulrik, additional, Leshnower, Bradley G., additional, Lutaakome, Joseph K., additional, Manian, Prasad, additional, Menon, Vidya, additional, Morales-Rull, Jose Luis, additional, O'Mahony, D. Shane, additional, Overcash, J. Scott, additional, Ramachandruni, Srikant, additional, Steingrub, Jay S., additional, Taha, Hassan S., additional, Waters, Michael, additional, Young, Barnaby E., additional, Phillips, Andrew N., additional, Murray, Daniel D., additional, Jensen, Tomas O., additional, Padilla, Maria L., additional, Sahner, David, additional, Shaw-Saliba, Katy, additional, Dewar, Robin L., additional, Teitelbaum, Marc, additional, Natarajan, Ven, additional, Rehman, M. Tauseef, additional, Pett, Sarah, additional, Hudson, Fleur, additional, Touloumi, Giota, additional, Brown, Samuel M., additional, Self, Wesley H., additional, Chang, Christina C., additional, Sánchez, Adriana, additional, Weintrob, Amy C., additional, Hatlen, Timothy, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Reilly, Cavan S., additional, Garbes, Pedro, additional, Esser, Mark T., additional, Templeton, Alison, additional, Babiker, Abdel G., additional, Davey, Victoria J., additional, Gelijns, Annetine C., additional, Higgs, Elizabeth S., additional, Kan, Virginia, additional, Matthews, Gail, additional, Thompson, B. Taylor, additional, Neaton, James D., additional, Lane, H. Clifford, additional, and Lundgren, Jens D., additional

Published
2022
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21. Tixagevimab/Cilgavimab for Treatment of Hospitalised COVID-19 Patients: A Randomised, Double-Blind, Phase 3 Trial

Author

Holland, Thomas L., primary, Ginde, Adit A., additional, Paredes, Roger, additional, Murray, Thomas A., additional, Engen, Nicole, additional, Grandits, Greg, additional, Vekstein, Andrew, additional, Ivey, Noel, additional, Mourad, Ahmad, additional, Sandkovsky, Uriel, additional, Gottlieb, Robert L., additional, Berhe, Mezgebe, additional, Jain, Mamta, additional, Marines-Price, Rubria, additional, Tchamba Agbor Agbor, Barbine, additional, Mateu, Lourdes, additional, Espana-Cueto, Sergio, additional, Llados, Gemma, additional, Mylonakis, Eleftherios, additional, Rogers, Ralph, additional, Shehadeh, Fadi, additional, Filbin, Michael R., additional, Hibbert, Kathryn A., additional, Kim, Kami, additional, Tran, Thanh, additional, Morris, Peter E., additional, Cassity, Evan P., additional, Trautner, Barbara, additional, Pandit, Lavannya M., additional, Knowlton, Kirk U., additional, Leither, Lindsay, additional, Matthay, Michael A., additional, Rogers, Angela J., additional, Drake, Wonder, additional, Jones, Beatrice, additional, Poulakou, Garyfallia, additional, Syrigos, Konstantinos N., additional, Fernandez-Cruz, Eduardo, additional, Di Natale, Marisa, additional, Almasri, Eyad, additional, Balerdi-Sarasola, Leire, additional, Bhagani, Sanjay R., additional, Boyle, Katherine L., additional, Casey, Jonathan D., additional, Chen, Peter, additional, Douin, David J., additional, Files, D. Clark, additional, Günthard, Huldrych F., additional, Hite, R. Duncan, additional, Hyzy, Robert C., additional, Khan, Akram, additional, Kibirige, Moses, additional, Kidega, Robert, additional, Kimuli, Ivan, additional, Kiweewa, Francis, additional, Jensen, Jens Ulrik Stæhr, additional, Leshnower, Bradley G., additional, Lutaakome, Joseph K., additional, Manian, Prasad, additional, Menon, Vidya, additional, Morales-Rull, Jose Luis, additional, O&apos;Mahony, Darragh, additional, Overcash, J. Scott, additional, Ramachandruni, Srikant, additional, Steingrub, Jay S., additional, Taha, Hassan S., additional, Waters, Michael, additional, Young, Barnaby E., additional, Phillips, Andrew N., additional, Murray, Daniel D., additional, Jensen, Tomas O., additional, Padilla, Maria L., additional, Sahner, David, additional, Shaw-Saliba, Katy, additional, Dewar, Robin L., additional, Teitelbaum, Marc, additional, Natarajan, Ven, additional, Rehman, M. Tauseef, additional, Pett, Sarah, additional, Hudson, Fleur, additional, Touloumi, Giota, additional, Brown, Samuel M., additional, Self, Wesley H., additional, Chang, Christina C., additional, Sanchez, Adriana, additional, Weintrob, Amy C., additional, Hatlen, Timothy, additional, Grund, Birgit, additional, Sharma, Shweta, additional, Reilly, Cavan S., additional, Garbes, Pedro, additional, Esser, Mark T., additional, Templeton, Alison, additional, Babiker, Abdel G., additional, Davey, Victoria J., additional, Gelijns, Annetine C., additional, Higgs, Elizabeth S., additional, Kan, Virginia, additional, Matthews, Gail, additional, Thompson, B. Taylor, additional, Neaton, James D., additional, Lane, H. Clifford, additional, and Lundgren, Jens, additional

Published
2022
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24. mTORC1 is a mechanosensor that regulates surfactant function and lung compliance during ventilator-induced lung injury

Author

Lee, Hyunwook, primary, Fei, Qinqin, additional, Streicher, Adam, additional, Zhang, Wenjuan, additional, Isabelle, Colleen, additional, Patel, Pragi, additional, Lam, Hilaire C., additional, Arciniegas-Rubio, Antonio, additional, Pinilla-Vera, Miguel, additional, Amador-Munoz, Diana P., additional, Barragan-Bradford, Diana, additional, Higuera-Moreno, Angelica, additional, Putman, Rachel K., additional, Sholl, Lynette M., additional, Henske, Elizabeth P., additional, Bobba, Christopher M., additional, Higuita-Castro, Natalia, additional, Shalosky, Emily M., additional, Hite, R. Duncan, additional, Christman, John W., additional, Ghadiali, Samir N., additional, Baron, Rebecca M., additional, and Englert, Joshua A., additional

Published
2021
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27. Implementation of Protocolized Care in ARDS Improves Outcomes

Author

Duggal, Abhijit, primary, Panitchote, Anupol, additional, Siuba, Matthew, additional, Krishnan, Sudhir, additional, Torbic, Heather, additional, Hastings, Andrei, additional, Mehkri, Omar, additional, Hanane, Tarik, additional, Hatipoglu, Umur, additional, Hite, R Duncan, additional, and Mireles-Cabodevila, Eduardo, additional

Published
2020
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28. Surfactant phospholipid changes after antigen challenge: a role for phosphatidylglycerol in dysfunction

Author

Hite, R. Duncan, Seeds, Michael C., Bowton, David L., Grier, Bonnie L., Safta, Anca M., Balkrishnan, Rajesh, Waite, B. Moseley, and Bass, David A.

Subjects
Asthma -- Research, Asthma -- Physiological aspects, Biological sciences
Abstract

In asthma, inflammation-mediated surfactant dysfunction contributes to increased airway resistance, but the mechanisms for dysfunction are not understood. To test mechanisms that alter surfactant function, atopic asthmatics underwent endobronchial antigen challenge and bronchoalveolar lavage (BAL). BAL fluids were sequentially separated into cells, surfactant, and supernatant, and multiple end points were analyzed. Each end point's unique relationship to suffactant dysfunction was determined. Our results demonstrate that minimum surface tension ([[gamma].sub.min]) of surfactant after antigen challenge was significantly increased with a spectrum of responses that included dysfunction in 6 of 13 asthmatics. Antigen challenge significantly altered the partitioning of surfactant phospholipid measured as a decreased ratio of large surfactant aggregates (LA) to small surfactant aggregates (SA), LA/SA ratio. Phosphatidylglycerol (PG) was significantly reduced in the LA of the dysfunctional asthmatic BALs. There was a corresponding significant increase in the ratio of phosphatidylcholine to PG, which strongly correlated with both increased [[gamma].sub.min] and decreased LA/SA. Altered surfactant phospholipid properties correlated with surfactant dysfunction as well or better than either increased eosinophils or protein. Secretory phospholipase activity, measured in vitro, increased after antigen challenge and may explain the decrease in surfactant PG. In summary, alteration of phospholipids, particularly depletion of PG, in the LA of surfactant may be an important mechanism in asthma-associated surfactant dysfunction. phospholipids; phospholipases; surface-active agents; eosinophils; lung injury

Published
2005

29. Lysophospholipid generation and phosphatidylglycerol depletion in phospholipase [A.sub.2]-mediated surfactant dysfunction

Author

Hite, R. Duncan, Seeds, Michael C., Safta, Anca M., Jacinto, Randolph B., Gyves, Julianna I., Bass, David A., and Waite, B. Moseley

Subjects
Respiratory tract diseases -- Research, Respiratory tract diseases -- Physiological aspects, Lungs -- Research, Lungs -- Physiological aspects, Lungs -- Injuries, Pulmonary surfactant -- Research, Pulmonary surfactant -- Physiological aspects, Biological sciences
Abstract

Pulmonary surfactant's complex mixture of phospholipids and proteins reduces the work of breathing by lowering alveolar surface tension during respiration. One mechanism of surfactant damage appears to be the hydrolysis of phospholipid by phospholipases activated in the inflamed lung. Humans have several candidate secretory phospholipase [A.sub.2] ([sPLA.sub.2]) enzymes in lung cells and infiltrating leukocytes that could damage extracellular surfactant. We considered two mechanisms of surfactant disruption by five human [sPLA.sub.2]s, including generation of lysophospholipids and the depletion of specific phospholipids. All five [sPLA.sub.2]s studied ultimately caused surfactant dysfunction. Each enzyme exhibited a different pattern of hydrolysis of surfactant phospholipids. Phosphatidylcholine, the major phospholipid in surfactant and the greatest potential source for generation of lysophospholipids, was susceptible to hydrolysis by group IB, group V, and group X [sPLA.sub.2]s, but not group IIA or IID. Group IIA hydrolyzed both phosphatidylethanolamine and phosphatidylglycerol, whereas group lid was active against only phosphatidylglycerol. Thus, with groups IB and X, the generation of lysophospholipids corresponded with surfactant dysfunction. However, hydrolysis of and depletion of phosphatidylglycerol had a greater correlation with surfactant dysfunction for groups IIA and IID. Surfactant dysfunction caused by group V [sPLA.sub.2] is less clear and may be the combined result of both mechanisms. lung injury; asthma; surface tension

Published
2005

33. List of Contributors

Author

Ahmed, Moustafa, primary, Allen, A. Katie, additional, Andrews, Penny, additional, Annane, Djillali, additional, Arkoosh, Valerie A., additional, Augoustides, John G.T., additional, Badia, Joan R., additional, Baranov, Dimitry, additional, Barie, Philip S., additional, Barbul, Adrian, additional, Bates, John, additional, Baudouin, Simon V., additional, Bellomo, Rinaldo, additional, Berger, Mette M., additional, Bitan, Yuval, additional, Bittner, Edward A., additional, Bouchard, Josée, additional, Brahmamdam, Pavan, additional, Brainard, Jason, additional, Brame, Aimee, additional, Braslow, Benjamin, additional, Brennan, John, additional, Brito, Veronica, additional, Broccard, Alain F., additional, Cahill, Naomi E., additional, Cecconi, Maurizio, additional, Cereda, Maurizio, additional, Chandler, John, additional, Cherry-Bukowiec, Jill, additional, Christie, Jason D., additional, Cone, Terence M., additional, Contreras, Maya, additional, Cooper, David James, additional, Coopersmith, Craig M., additional, Cotton, Bryan A., additional, Curtis, Caitlin S., additional, Dalton, Heidi, additional, Dechert, Tracey, additional, Deitch, Edwin A., additional, Deutschman, Clifford S., additional, Donagh, Carol, additional, Dorman, Todd, additional, Drabek, Tomas, additional, Dunlop, Craig, additional, Durbin, Charles G., additional, Eachempati, Soumitra R., additional, Eid, Luminita, additional, El Solh, Ali A., additional, Ellis, John E., additional, Ely, E. Wesley, additional, Evans, Timothy W., additional, Fang, Adam, additional, Fanning, Niall, additional, Ferguson, Niall D., additional, Finan, Katherine, additional, Fitzgerald, Marianne, additional, Fleisher, Lee A., additional, Flynn, Noel M., additional, Frogel, Jonathan K., additional, Garmon, Wesley M., additional, Garpestad, Erik, additional, Gauglitz, Gerd G., additional, Gervasio, Jane M., additional, Gordon, Anthony C., additional, Gracias, Vicente, additional, Gutsche, Jacob, additional, Habashi, Nader M., additional, Hadler, Rachel A., additional, Halickman, Isaac, additional, Halpern, Scott D., additional, Hanson, C. William, additional, Hassett, Patrick, additional, Hata, J. Steven, additional, Hayes, Ivan, additional, Heyland, Daren K., additional, Hill, Nicholas S., additional, Hirshberg, Eliotte, additional, Hite, R. Duncan, additional, Holena, Daniel, additional, Hollenberg, Steven M., additional, Horak, Jiri, additional, Hotchkiss, Richard S., additional, Hotchkiss, John R., additional, Jeschke, Marc G., additional, Kahn, Jeremy M., additional, Karhadkar, Sunil, additional, Keegan, Mark T., additional, Kelz, Rachel R., additional, Kevin, Leo G., additional, Khadaroo, Rachel G., additional, Kleinschmidt, Kurt, additional, Kochanek, Patrick M., additional, Kofke, W. Andrew, additional, Kohl, Benjamin A., additional, Koyner, Jay L., additional, Kucik, Corry J., additional, Kudsk, Kenneth A., additional, Laffey, John G., additional, Lappin, David, additional, Le Roux, Peter, additional, Levine, Joshua M., additional, Levy, Richard J., additional, Lipsett, Pamela A., additional, Liu, Kathleen D., additional, MacDougall, Conan, additional, MacKenzie, Larami, additional, Marsh, Brian, additional, Marshall, John C., additional, Martyn, Jeevendra A., additional, Matthay, Michael A., additional, Maze, Mervyn, additional, McAuley, Danny F., additional, Dermott, Gráinne Mc, additional, McFadden, E.R., additional, McKenny, Michael, additional, McKinney, James S., additional, Meade, Maureen O., additional, Mehta, Ravindra L., additional, Messé, Steven R., additional, Messer, Ben, additional, Moitra, Vivek K., additional, Morris, Alan H., additional, Murray, Patrick T., additional, Napolitano, Lena, additional, Neligan, Patrick J., additional, Neves, Ana Paula, additional, Nichol, Alistair, additional, Niederman, Michael S., additional, Nix, Sean A., additional, Nunnally, Mark E., additional, O'Donoghue, Rory, additional, O'Connor, Michael, additional, O'Neal, Hollis R., additional, O'Regan, Anthony, additional, O'Shaughnessy, Michelle, additional, Oddo, Mauro, additional, Ong, Thida, additional, Opal, Steven M., additional, Pandharipande, Pratik P., additional, Patrozou, Eleni, additional, Pettila, Ville, additional, Pisarenko, Vadim, additional, Plante, Lauren A., additional, Powner, David J., additional, Preiser, Jean-Charles, additional, Pryor, John P., additional, Quill, Caroline M., additional, Rao, Madhav V., additional, Redahan, Lynn, additional, Reddan, Donal, additional, Reilly, Patrick M., additional, Rhodes, Andrew, additional, Riordan, William P., additional, Russell, James A., additional, Ryu, Ho-Geol, additional, Sanders, Robert D., additional, Sarani, Babak, additional, Scully, Michael, additional, Shah, Chirag V., additional, Shiroff, Adam, additional, Siau, Chuin, additional, Sims, Carrie A., additional, Stapleton, Renee D., additional, Statler, Kimberly D., additional, Stawicki, S. Peter, additional, Steel, Andrew C., additional, Stewart, Thomas E., additional, Strong, Michelle L., additional, Subramaniam, Ramakrishnan, additional, Sweeney, Rob Mac, additional, Terhune, Kyla P., additional, Thom, Stephen R., additional, Thomas, Joss, additional, Tisherman, Samuel A., additional, Tuccillo, Maria, additional, Tung, Avery, additional, Uchino, Shigehiko, additional, Veloso, Tatiana, additional, Vincent, Jean-Louis, additional, Walshe, Criona M., additional, Ware, Lorraine B., additional, Warren, Edward, additional, Weavind, Liza, additional, Weier, Alan, additional, Weiss, Yoram G., additional, Weiss, Stuart Joel, additional, Wendell, Linda C., additional, Whyte, Pauline, additional, Wiener-Kronish, Jeanine, additional, Yang, Katherine, additional, and Zafirova, Zdravka, additional

Published
2010
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35. Pulmonary type II cell hypertrophy and pulmonary lipoproteinosis are features of chronic IL-13 exposure

Author

Homer, Robert J., Zheng, Tao, Geoff, Chupp, He, Susan, Zhu, Zhou, Chen, Quingshen, Ma, Bing, Hite, R. Duncan, Gobran, Laurice, I., Rooney, Seamus A., and Elias, Jack A.

Subjects
Hypertrophy -- Evaluation, Lipoproteins -- Evaluation, Lungs -- Physiological aspects, Asthma -- Evaluation, Pulmonary fibrosis -- Physiological aspects, Interleukins -- Physiological aspects, Biological sciences
Abstract

Pulmonary type II cell hypertrophy and pulmonary lipoproteinosis are features of chronic IL-13 exposure. Am J Physiol Lung Cell Mol Physiol 283: L52-L59, 2002. First published February 15, 2002; 10.1152/ajplung.00438.2001.--Interleukin (IL)-13, a key mediator of Th2-mediated immunity, contributes to the pathogenesis of asthma and other pulmonary diseases via its ability to generate fibrosis, mucus metaplasia, eosinophilic inflammation, and airway hyperresponsiveness. In these studies, we compared surfactant accumulation in wild-type mice and mice in which IL-13 was overexpressed in the lung. When compared with littermate controls, transgenic animals showed alveolar type II cell hypertrophy under light and electron microscopy. Over time, their alveoli also filled with surfactant in a pulmonary alveolar proteinosis pattern. At the same time, prominent interstitial fibrosis occurs. Bronchoalveolar lavage fluid from these mice had a three- to sixfold increase in surfactant phospholipids. Surfactant proteins (SP)-A, -B, and -C showed two- to threefold increases, whereas SP-D increased 70-fold. These results indicate that IL-13 is a potent stimulator of surfactant phospholipid and surfactant accumulation in the lung. IL-13 may therefore play a central role in the broad range of chronic pulmonary conditions in which fibrosis, type II cell hypertrophy, and surfactant accumulation occur. asthma; type 2 pneumocytes; pulmonary fibrosis; interleukin-13

Published
2002

39. Response

Author

Morris, Alan H., Hirshberg, Eliotte, Miller, Russell R., III, Statler, Kimberly D., and Hite, R. Duncan

Published
2011
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40. Three Alveolar Phenotypes Govern Lung Function in Murine Ventilator-Induced Lung Injury

Author

Smith, Bradford J., primary, Roy, Gregory S., additional, Cleveland, Alyx, additional, Mattson, Courtney, additional, Okamura, Kayo, additional, Charlebois, Chantel M., additional, Hamlington, Katharine L., additional, Novotny, Michael V., additional, Knudsen, Lars, additional, Ochs, Matthias, additional, Hite, R. Duncan, additional, and Bates, Jason H. T., additional

Published
2020
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43. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure

Author

Fowler, Alpha A., primary, Truwit, Jonathon D., additional, Hite, R. Duncan, additional, Morris, Peter E., additional, DeWilde, Christine, additional, Priday, Anna, additional, Fisher, Bernard, additional, Thacker, Leroy R., additional, Natarajan, Ramesh, additional, Brophy, Donald F., additional, Sculthorpe, Robin, additional, Nanchal, Rahul, additional, Syed, Aamer, additional, Sturgill, Jamie, additional, Martin, Greg S., additional, Sevransky, Jonathan, additional, Kashiouris, Markos, additional, Hamman, Stella, additional, Egan, Katherine F., additional, Hastings, Andrei, additional, Spencer, Wendy, additional, Tench, Shawnda, additional, Mehkri, Omar, additional, Bindas, James, additional, Duggal, Abhijit, additional, Graf, Jeanette, additional, Zellner, Stephanie, additional, Yanny, Lynda, additional, McPolin, Catherine, additional, Hollrith, Tonya, additional, Kramer, David, additional, Ojielo, Charles, additional, Damm, Tessa, additional, Cassity, Evan, additional, Wieliczko, Aleksandra, additional, and Halquist, Matthew, additional

Published
2019
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44. Efficacy of extracorporeal membrane oxygenation in 2009 influenza A (H1N1)

Author

Park, Pauline K., Dalton, Heidi J., Bartlett, Robert H., Morris, Alan H., Hirshberg, Eliotte, Miller, Russell R., Statler, Kimberly D., and Hite, R. Duncan

Subjects
Blood oxygenation, Extracorporeal -- Usage, Blood oxygenation, Extracorporeal -- Safety and security measures, Swine influenza -- Care and treatment, Health
Published
2010

45. Hydrolysis of surfactant-associated phosphatidylcholine by mammalian secretory phospholipases A2

Author

Hite, R. Duncan, Seeds, Michael C., Jacinto, Randy B., Balasubramanian, R., Waite, Moseley, and Bass, David

Subjects
Phospholipases -- Research, Hydrolysis -- Research, Lecithin -- Research, Pulmonary surfactant -- Research, Lungs -- Physiological aspects, Biological sciences
Abstract

The effect of multiple secretory phospholipases A2 on lung surfactant was investigated, as well as their ability to release fatty acids, release lysophospholipids and increase the minimum surface tension on a pulsating bubble surfactometer. Findings demonstrated that mammalian group I airway secretory phospholipase A2 (sPLA2) hydrolyzed phosphatidylcholine (PC) and increased the minimum surface tension. In contrast, mammalian group II sPLA2 demonstrated limited hydrolysis of PC and did not increase minimum surface tension.

Published
1998

46. Early Neuromuscular Blockade in the Acute Respiratory Distress Syndrome

Author

National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, Moss, Marc, Huang, David T, Brower, Roy G, Ferguson, Niall D, Ginde, Adit A, Gong, MN, Grissom, Colin K, Gundel, Stephanie, Hayden, Douglas, Hite, R Duncan, Hou, Peter C, Hough, Catherine L, Iwashyna, Theodore J, Khan, Akram, Liu, Kathleen D, Talmor, Daniel, Thompson, B Taylor, Ulysse, Christine A, Yealy, Donald M, and Angus, Derek C

Subjects
Adult, Male, Clinical Trials and Supportive Activities, Conscious Sedation, Bioengineering, Cardiovascular, Medical and Health Sciences, Positive-Pressure Respiration, Rare Diseases, Clinical Research, General & Internal Medicine, Humans, Treatment Failure, Hospital Mortality, Lung, Acute Respiratory Distress Syndrome, Aged, Respiratory Distress Syndrome, National Heart, Middle Aged, Combined Modality Therapy, Good Health and Well Being, Atracurium, Neuromuscular Blockade, Respiratory, and Blood Institute PETAL Clinical Trials Network, Female, Neuromuscular Blocking Agents
Abstract

BackgroundThe benefits of early continuous neuromuscular blockade in patients with acute respiratory distress syndrome (ARDS) who are receiving mechanical ventilation remain unclear.MethodsWe randomly assigned patients with moderate-to-severe ARDS (defined by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen of

Published
2019

49. Implementation of Protocolized Care in ARDS Improves Outcomes.

Author

Duggal, Abhijit, Panitchote, Anupol, Siuba, Matthew, Krishnan, Sudhir, Torbic, Heather, Hastings, Andrei, Mehkri, Omar, Hanane, Tarik, Hatipoglu, Umur, Hite, R. Duncan, and Mireles-Cabodevila, Eduardo

Subjects
ADULT respiratory distress syndrome treatment, MULTIVARIATE analysis, FISHER exact test, MANN Whitney U Test, APACHE (Disease classification system), HUMAN services programs, TREATMENT effectiveness, COMPARATIVE studies, T-test (Statistics), CHI-squared test, DESCRIPTIVE statistics, PATIENT compliance, LOGISTIC regression analysis
Abstract

BACKGROUND: Treatments for ARDS that improve patient outcomes include use of lung-protective ventilation, prone ventilation, and conservative fluid management. Implementation of ARDS protocols via educational programs might improve adherence and outcomes. The objective of this study was to investigate the effects of an ARDS protocol implementation on outcomes and adherence with ARDS guidelines. METHODS: This was a single-center, interventional, comparative study before and after protocol implementation. Staff education for the ARDS protocol was implemented between June 2014 and May 2015. A retrospective cohort analysis was conducted during between January 2012 and May 2014 (pre-protocol) and between June 2015 and June 2017 (post-protocol). A total of 450 subjects with ARDS were included. After propensity score matching, 432 subjects were analyzed. Of those, 330 subjects were treated after protocol implementation. RESULTS: The median (interquartile range [IQR]) plateau pressure and tidal volume over the first 3 d decreased significantly after protocol implementation (30.5 [IQR 24.2-33] vs 25.5 [IQR 21.7-30], P 5 .01 and 7.65 vs 7.4 mL/kg predicted body weight, P 5 .032, respectively). The percentage of subjects with unsafe tidal volume (> 10 mL/kg predicted body weight) decreased (14.4% vs 5.8%, P 5 .02). The percent- age of subjects with safe plateau pressure (͌ 30 cm H2O) increased (47.4% vs 76.5%, P < .001). PEEP deviation from the ARDSNet PEEP/FIO2 table was significantly lower after the implementation. Mortality at 28 and 90 days improved after implementation (53.9% vs 41.8% and 61.8% vs 48.2%, respectively). Adjusted odds ratios for 28-d and 90-d mortality were 0.47 (95% CI 0.28-0.78) and 0.45 (95% CI 0.27-0.76), respectively. CONCLUSIONS: ARDS protocol implementation was associated with improved survival and rate of adherence. [ABSTRACT FROM AUTHOR]

Published
2021
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