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1. Diabetes mellitus, glycaemic control, and severe COVID-19 in the Australian critical care setting: A nested cohort study

Author

Mark P. Plummer, Louise Rait, Mark E. Finnis, Craig J. French, Samantha Bates, James Douglas, Mansi Bhurani, Tessa Broadley, Tony Trapani, Adam M. Deane, Andrew A. Udy, Aidan J.C. Burrell, Adam Visser, Adrian Mattke, Adrian Regli, Alan Rashid, Alexis Tabah, Alison Walker, Allen Cheng, Amanda Corley, Andrew Udy, Anil Ramnani, Anthony Eidan, Bart DeKeulenaer, Benjamin Reddi, Brent Richards, Cameron Knott, Cara Moore, Carmel Delzoppo, Catherine Boschert, Catherine Tacon, Craig French, Danielle Austin, David Brewster, David Cooper, David Crosbie, David Hawkins, Edda Jessen, Eduardo Martinez, Edward Fysh, Edward Litton, Felix Oberender, Forbes McGain, Gavin Salt, Glenn Eastwood, Gopal Taori, Hayden White, Hergen Buscher, Ian Seppelt, Isabel Anne Leditschke, Janelle Young, Jayshree Lavana, Jeremy Cohen, Jessica Lugsdin, John Botha, John Santamaria, Jonathan Barrett, Kasha Singh, Kevin Laupland, Khaled El-Khawas, Kristine Estensen, Kush Deshpande, Kyle White, Leigh Fitzpatrick, Lewis Campbell, Mahesh Ramanan, Manoj Saxena, Marion Kainer, Mark Kol, Mark Page, Mark Plummer, Martin Sterba, Matthew Anstey, Matthew Brain, Matthew Maiden, Myrene Kilminster, Naomi Hammond, Neeraj Bhadange, Nicole Humphreys, Paras Jain, Paul Azzi, Paul Secombe, Paula Lister, Peter Chan, Peter McCanny, Phillip Britton, Pierre Janin, Ravi Krishnamurthy, Ravikiran Sonawane, Ravindranath Tiruvoipati, Richard Totaro, Rinaldo Bellomo, Ritesh Sanghavi, Sandra Peake, Shailesh Bihari, Shane George, Simon Erickson, Steve Webb, Subhash Arora, Subodh Ganu, Thomas Rozen, Toni McKenna, Umesh Kadam, Vineet Nayyar, Wei Han Choy, and Wisam Albassam

Subjects
Emergency Nursing, Critical Care Nursing
Abstract

Internationally, diabetes mellitus is recognised as a risk factor for severe COVID-19. The relationship between diabetes mellitus and severe COVID-19 has not been reported in the Australian population.The objective of this study was to determine the prevalence of and outcomes for patients with diabetes admitted to Australian intensive care units (ICUs) with COVID-19.This is a nested cohort study of four ICUs in Melbourne participating in the Short Period Incidence Study of Severe Acute Respiratory Infection (SPRINT-SARI) Australia project. All adult patients admitted to the ICU with COVID-19 from 20 February 2020 to 27 February 2021 were included. Blood glucose and glycated haemoglobin (HbA1c) data were retrospectively collected. Diabetes was diagnosed from medical history or an HbA1c ≥6.5% (48 mmol/mol). Hospital mortality was assessed using logistic regression.There were 136 patients with median age 58 years [48-68] and median Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 14 [11-19]. Fifty-eight patients had diabetes (43%), 46 patients had stress-induced hyperglycaemia (34%), and 32 patients had normoglycaemia (23%). Patients with diabetes were older, were with higher APACHE II scores, had greater glycaemic variability than patients with normoglycaemia, and had longer hospital length of stay. Overall hospital mortality was 16% (22/136), including nine patients with diabetes, nine patients with stress-induced hyperglycaemia, and two patients with normoglycaemia.Diabetes is prevalent in patients admitted to Australian ICUs with severe COVID-19, highlighting the need for prevention strategies in this vulnerable population.

Published
2022
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2. Rapid Translation of COVID-19 Preprint Data into Critical Care Practice

Author

Aidan J. C. Burrell, Ary Serpa Neto, Tony Trapani, Tessa Broadley, Craig French, Andrew A. Udy, Adam Visser, Adrian Mattke, Adrian Regli, Alan Rashid, Alexis Tabah, Alison Walker, Allen Cheng, Amanda Corley, Andrew Udy, Anil Ramnani, (Isabel) Anne Leditschke, Anthony Eidan, Bart DeKeulenaer, Baumik Mevavala, Ben Mulholland, Benjamin Reddi, Brent Richards, Cameron Knott, Cara Moore, Carmel Delzoppo, Catherine Boschert, Catherine Tacon, Claire Corrigan, Danielle Austin, David Brewster, David Cooper, David Crosbie, David Hawkins, Edda Jessen, Eduardo Martinez, Edward Fysh, Edward Litton, Felix Oberender, Forbes McGain, Gavin Salt, Glenn Eastwood, Gopal Taori, Hannah Thompson, Hayden White, Hergen Buscher, Ian Seppelt, Ifrah Khan, Janelle Young, Jayshree Lavana, Jeremy Cohen, Jessica Lugsdin, Jill Garlick, Jim Buttery, John Botha, John Santamaria, Jonathan Barrett, Kasha Singh, Kevin Laupland, Khaled El-Khawas, Kristine Estensen, Kush Deshpande, Kyle White, Leigh Fitzpatrick, Lewis Campbell, Mahesh Ramanan, Manoj Saxena, Marie Draper, Marion Kainer, Mark Kol, Mark Page, Mark Plummer, Martin Sterba, Matthew Anstey, Matthew Brain, Matthew Maiden, Myrene Kilminster, Naomi Hammond, Neeraj Bhadange, Nicole Humphreys, Paras Jain, Paul Azzi, Paul Secombe, Paula Lister, Peter Chan, Peter McCanny, Phillip Britton, Pierre Janin, Rashmi Runiyar, Ravi Krishnamurthy, Ravikiran Sonawane, Ravindranath Tiruvoipati, Rebecca Jessup, Richard Totaro, Rinaldo Bellomo, Ritesh Sanghavi, Samantha Bates, Sandra Peake, Shailesh Bihari, Shane George, Sharon Waterson, Simon Erickson, Steve Webb, Subhash Arora, Subodh Ganu, Thomas Rozen, Toni McKenna, Umesh Kadam, Vineet Nayyar, Wei Han Choy, Wisam Albassam, and Intensive Care Medicine

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, Critical Care, medicine.medical_treatment, MEDLINE, Disease, Critical Care and Intensive Care Medicine, medicine.disease_cause, Dexamethasone, 03 medical and health sciences, 0302 clinical medicine, Adrenal Cortex Hormones, Intensive care, Pandemic, Correspondence, medicine, Humans, 030212 general & internal medicine, Practice Patterns, Physicians', Intensive care medicine, Survival rate, Coronavirus, Aged, Mechanical ventilation, Aged, 80 and over, Clinical Trials as Topic, business.industry, Australia, COVID-19, Middle Aged, COVID-19 Drug Treatment, Survival Rate, Treatment Outcome, 030228 respiratory system, Female, Guideline Adherence, business, medicine.drug
Abstract

To the Editor: The global coronavirus disease (COVID-19) pandemic has seen a significant increase in the use of preprint services to enable the widespread dissemination of research findings (1). However, whether such facilities influence practice change is currently unknown. Here, we describe the impact of the preprint release and eventual publication of the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial (2) on corticosteroid use in clinical practice in Australian ICUs. The RECOVERY trial tested the efficacy of dexamethasone (6 mg by mouth or intravenously for up to 10 d) in hospitalized patients with clinically suspected or confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and demonstrated a reduction in 28-day mortality, particularly in those receiving either mechanical ventilation or oxygen. Before these results, the Australian and New Zealand Intensive Care Society COVID-19 guidelines recommended against the routine use of corticosteroids (3).

Published
2020

3. Association between augmented renal clearance and clinical outcomes in patients receiving β-lactam antibiotic therapy by continuous or intermittent infusion: a nested cohort study of the BLING-II randomised, placebo-controlled, clinical trial

Author

Andrew A. Udy, Joel M. Dulhunty, Jason A. Roberts, Joshua S. Davis, Steven A.R. Webb, Rinaldo Bellomo, Charles Gomersall, Charudatt Shirwadkar, Glenn M. Eastwood, John Myburgh, David L. Paterson, Therese Starr, Sanjoy K. Paul, Jeffrey Lipman, Glenn Eastwood, Leah Peck, Helen Young, Catherine Boschert, Jason Fletcher, Julie Smith, Kiran Nand, Treena Sara, Amy Harney, Helen Rodgers, Frank Van Haren, Sally Clarke, David Durham, Catherine Hannan, Elisha Matheson, Kate Schwartz, Karen Thomas, Allison Bone, Claire Cattigan, Tania Elderkin, Tania Salerno, Robert Cameron, Katrina Ellis, Sheridan Hatter, Joshua Davis, Milind Sanap, Natalie Soar, Josette Wood, Karen Chan, Aaron Heffernan, Nai An Lai, Catherine Moss, Kate Sheehy, Maree Duroux, Megan Ratcliffe, Samantha Shone, Timothy Warhurst, Joel Dulhunty, Rachel Dunlop, David Paterson, Jason Roberts, Janine Stuart, Andrew Udy, David Cooper, Rick McAllister, Steve Webb, Andrew Cheng, Deborah Inskip, Jennene Miller, Serena Knowles, Claire Reynolds, Sam Rudham, Stuart Baker, Kristy Hepburn, Brigit Roberts, Paul Woods, Indranil Chatterjee, Judy Smith, Martin Cullen, Jing Kong, Vineet Nayyar, Christina Whitehead, Patricia Leung, Eileen Gilder, Lianne McCarthy, Shay McGuiness, Rachael Parke, Kirsten Benefield, Yan Chen, Colin McArthur, Lynette Newby, Seton Henderson, Jan Mehrtens, Sascha Noble, Lesley Chadwick, Ross Freebain, Chantal Hogan, Alex Kazemi, Laura Rust, Rima Song, Anna Tilsley, Anthony Williams, John Durning, Robert Frengley, Mary La Pine, Geoff McCracken, Swarna Baskar Sharma, Lynn Andrews, Richard Dinsdale, Anna Hunt, Sally Hurford, Diane Mackle, Jessica Ongley, Paul Young, Marin Kollef, John Turnidge, Sanjoy Paul, Udy, Andrew A, Dulhunty, Joel M, Roberts, Jason A, Davis, Joshua S, Turnidge, John, and Paul, Sanjoy K

Subjects
Adult, Male, Microbiology (medical), augmented renal clearance, medicine.medical_specialty, Metabolic Clearance Rate, medicine.medical_treatment, Renal function, beta-Lactams, Placebo, Cohort Studies, sepsis, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Sepsis, Internal medicine, medicine, Humans, critical illness, Pharmacology (medical), 030212 general & internal medicine, Renal replacement therapy, Infusions, Intravenous, Aged, Creatinine, business.industry, Organ dysfunction, Acute kidney injury, 030208 emergency & critical care medicine, Bacterial Infections, General Medicine, Middle Aged, medicine.disease, Anti-Bacterial Agents, Surgery, Clinical trial, Treatment Outcome, Infectious Diseases, chemistry, Female, medicine.symptom, business, ß-lactams, Cohort study
Abstract

Augmented renal clearance (ARC) is known to influence β-lactam antibiotic pharmacokinetics. This substudy of the BLING-II trial aimed to explore the association between ARC and patient outcomes in a large randomised clinical trial. BLING-II enrolled 432 participants with severe sepsis randomised to receive β-lactam therapy by continuous or intermittent infusion. An 8-h creatinine clearance (CLCr) measured on Day 1 was used to identify ARC, defined as CLCr ≥ 130 mL/min. Patients receiving any form of renal replacement therapy were excluded. Primary outcome was alive ICU-free days at Day 28. Secondary outcomes included 90-day mortality and clinical cure at 14 days following antibiotic cessation. A total of 254 patients were included, among which 45 (17.7%) manifested ARC [median (IQR) CLCr 165 (144–198) mL/min]. ARC patients were younger (P

Published
2017
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4. The association between platelet transfusions and bleeding in critically ill patients with thrombocytopenia

Author

Donald M. Arnold, Francois Lauzier, Martin Albert, David Williamson, Na Li, Ryan Zarychanski, Chip Doig, Lauralyn McIntyre, Andreas Freitag, Mark Crowther, Lois Saunders, France Clarke, Rinaldo Bellomo, Ismael Qushmaq, Renato D. Lopes, Diane Heels‐Ansdell, Kathryn Webert, Deborah Cook, Rick Hall, Graeme Rocker, Lisa Julien, Debbie Wright, Caroline Roy, Judy Theriault, Susan Pleasance, Maureen Meade, Lori Hand, Christine Wynne, Mark Duffett, Michelle Kho, Nicole Zytaruk, John Granton, Andrea Matte, Paulina Farias, Leslie Chu, Nancy Brockest, Stephanie Go, Margaret McGrath‐Chong, Madison Dennis, Marc Lipkus, Emily Stern, Ryan Albert, Stephan Langevin, Alexis F Turgeon, Marie‐Claude Tremblay, Martine Blais, Maxime Beauparlant, Julie Asselin, Chantal Gagne, Marie Thibodeau, Germain Poirier, Sandrine Spearson, Isabelle Neas, Joe Pagliarello, Paul Hébert, Irene Watpool, Tracy McArdle, Claude Gaudert, Paule Marchand, Carson Davidson, Mary‐Jo Lewis, Erin Murphy, Julia Foxall, Yoanna Skrobik, Johanne Harvey, Stefania Chitu, Virginie Williams, Carole Sirois, Carole Nadon, Stephanie Dolle, Audrey‐Anne Gosselin, Patrice Deroy, Geeta Mehta, Sumesh Shah, Cheryl Ethier, Sam Tirgari, Lindsay Steinberg, Rod McDonald, Vidhya Sivanantham, Kristofer Bandayrel, Friederike Quittnat Pelletier, Marnie Kramer‐Kile, Maedean Brown, Scott Kim, Rob Fowler, Nicole Marinoff, Karen Code, Boris Bojilov, Derek Parsotam, John Marshall, Orla Smith, Beth Fry, Kerri Porretta, Yoon Lee, Jeanna Morrissey, Victoria Wen, John Muscedere, Miranda Hunt, Susan Fleury, Nicole Godfrey, Sharlene Hammond, Elizabeth Mann, Monica Myers, Amber Robinson, Donald Griesdale, Dean Chittock, Vinay Dhingra, Denise Foster, Maureen Gardner, Susan Logie, Roger Autio, Dara Davies, Pia Ganz, Laurie Smith, Peter Dodek, Victoria Alcuaz, Betty Jean Ashley, Sheilagh Mans, Niall Ferguson, James Stevenson, Joel Elman, Timothy Karachi, Tina Millen, Andrea Tkaczyk, Mike Jacka, Marleen Irwin, Carmen Chan, Leeca Sonnema, Kelly Marsh, Jennifer Maurer, Tamara Kreidl, Candice Varden, Carey Kinjerski, Christopher Doig, Stacy Ruddell, Linda Knox, Crystal Wilson, Kevin Champagne, Gordon Wood, Fiona Auld, Leslie Atkins, Bojan Paunovic, Nicole Marten, Kym Wiebe, Ellen McDonald, Sean Keenan, Steven Reynolds, Miroslav Svetik, Mary Van Osch, Jim Kutsogiannis, Patrica Thompson, Norine Whalen, Francois Lellouche, Marie‐Claude Ferland, Patrick Dussault, Caroline Jacob, Marie‐Eve Morneau, Nancy Laberge, Kosar Khwaja, Laura Banici, Lena Havell, Olivier Lesur, Francois Lamontagne, Sandra Proulx, Gerald Hollinger, Vasanti Shende, Vanessa Belcastro, Bill Plaxton, Anders Foss, Jonathan Eisenstat, Tammy Doerle, Michael Sharpe, Mona Madady, Jamie Cooper, Andrew Davies, Shirley Vallance, Cindy Weatherburn, Jasmin Board, Victoria Bennett, Simon Finfer, Naresh Ramakrishnan, Simon Bird, Julie Potter, Anne O’Connor, Susan Ankers, Jack Cade, Deborah Barge, Tania Caf, Belinda Howe, Glenn Eastwood, Leah Peck, Donna Goldsmith, Kim O’Sullivan, David Ernest, Sam Radford, Ann Whitfield, Anthony Cross, Suzanne Eliott, Jaspreet Sidhu, Inga Mercer, Angela Hamilton, John Botha, Jodi Vuat, Sharon Allsop, Nina Fowler, Tim Crozier, Jonathan Barrett, Chris Wright, Pauline Galt, Carly Culhane, Rebecca Ioannidis, Sue Burton, Marnie Reily, Cyveen Weeraratna, Ian Seppelt, Leonie Weisbrodt, Robyn Bond, Nepean Hospital, Justine Rivett, Stephanie O’Connor, Alex Poole, Clive Woolfe, Dorrilyn Rajbhandari, Caitlin Rees, John Edington, Jason Fletcher, Julie Smith, Catherine Boschert, Graham Reece, Treena Sara, Kiran Nand, Andrew Bersten, Alex Gallus, Elisha Matheson, Margie O’Callaghan, Neil Orford, Tania Elderkin, Melissa Fraser, Allison Bone, Tania Salerno, Anne Kinmonth, Subhash Arora, Bridget O’Bree, Katherine Shepherd, Alan –Quinn, Martin Sterba, Bronwyn Ruth Johnson, Renee Xu, Francisco Hill, Rajaram Ramadoss, Josette Wood, Marcelo Garcia da Rocha, Andréa Kramer, Martha Hädrich, Nilton Brandao, Cassiano Teixeira, Cíntia Roehrig, Juliana Zeni, Suzana Alves da Silva, Rubens Costa Filho, Renato Correa, Alves Moreira, Plínio N. Gomes, Rodrigo Biondi, Otavio Berwanger, Edson Romano, Anna Maria Buehler, Helio Penna Guimarães, Adriano Truffa, Rosana Nakamura, Lillian Mazza Barbosa, Jean Brennick, Sawsan Bassi, Mohammed Alsultan, Yaseen Arabi, Riette Brits, Jamal Alhashemi, Sanaa Shalabi, Yasser Mandourah, Nadeem Shaikh, Manal Al‐Hazmi, M. Ali Al‐Azem, Trevor Wyngaard, Barbara Smithson, Nicholas E Vlahakis, Laurie Meade, Michael Cox, Jackie O’Brien, Catherine Krause, Joseph Nates, Sajid Haque, Deidre Mooring, Rose Erfe, Paula Nickerson, Tony Sherry, John Smith, Barnaby Sanderson, Josephine Ng, John Brooks, Ling Lim, and Katie Lei

Subjects
medicine.medical_specialty, Anemia, Population, thrombocytopenia, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, law, Internal medicine, medicine, Platelet, education, transfusion, education.field_of_study, business.industry, Hazard ratio, Original Articles, Hematology, medicine.disease, mortality, Intensive care unit, Thrombosis, 3. Good health, critical care, Platelet transfusion, 030228 respiratory system, Online‐only Articles, platelets, Original Article, Medical emergency, hemorrhage, business, Cohort study
Abstract

Background Platelet transfusions are commonly used to treat critically ill patients with thrombocytopenia. Whether platelet transfusions are associated with a reduction in the risk of major bleeding is unknown. Patients/Methods Observational cohort study nested in a previous multicenter, randomized thromboprophylaxis trial in the intensive care unit (ICU). The objective was to evaluate the association between platelet transfusions and adjudicated major bleeding events. Platelet transfusion episodes were reviewed for timing of administration, product type, and dose. Major bleeding with and without platelet transfusions was adjusted for severity of thrombocytopenia, use of anti‐platelet agents, surgery and other covariates. Secondary outcomes were thrombosis, death in ICU and platelet count increment. Results Among 2,256 patients, 71 (3.1%) received 190 platelet transfusions. Of those, 121 (63.7%) were administered to 54 non‐bleeding, thrombocytopenic patients. Adjusted rates of major bleeding were not statistically different with or without the administration of platelet transfusions (hazard ratio for transfused patients 0.85; 95% confidence interval, 0.42‐1.72). We did not find a significant association between platelet transfusion use and thrombosis or death in ICU in adjusted analyses. Thrombocytopenia, anemia, major or minor bleeding and use of anticoagulants were associated with platelet transfusion administration. The median post‐transfusion platelet count increment was 20×109/L at 3.5 hours post‐transfusion. Conclusions Rates of major bleeding were not different for patients who did and did not receive platelet transfusions. Inferences were limited by the small number of transfused patients. Clinical trials are needed to better investigate the potential hemostatic benefit and potential harms of platelet transfusions for this high‐risk population.

Published
2017

5. Effect of hydrocortisone on mortality and organ support in patients with severe COVID-19

Author

Angus, Derek, Derde, Lennie, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen, Beane, Abigail, van Bentum-Puijk, Wilma, Berry, Lindsay, Bhimani, Zahra, Bonten, Marc, Bradbury, Charlotte, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Cheng, Allen, de Jong, Menno, Detry, Michelle, Estcourt, Lise, Fitzgerald, Mark, Goossens, Herman, Green, Cameron, Haniffa, Rashan, Higgins, Alisa, Horvat, Christopher, Hullegie, Sebastiaan, Kruger, Peter, Lamontagne, Francois, Lawler, Patrick, Linstrum, Kelsey, Litton, Edward, Lorenzi, Elizabeth, Marshall, John, Mcauley, Daniel, Mcglothin, Anna, Mcguinness, Shay, Mcverry, Bryan, Montgomery, Stephanie, Mouncey, Paul, Murthy, Srinivas, Nichol, Alistair, Parke, Rachael, Parker, Jane, Rowan, Kathryn, Sanil, Ashish, Santos, Marlene, Saunders, Christina, Seymour, Christopher, Turner, Anne, van de Veerdonk, Frank, Venkatesh, Balasubramanian, Zarychanski, Ryan, Berry, Scott, Lewis, Roger, Mcarthur, Colin, Webb, Steven, Gordon, Anthony, NIHR, Hôpital Raymond Poincaré [AP-HP], Writing Committee for the REMAP-CAP Investigators, Farah Al-Beidh, Derek Angus, Djillali Annane, Yaseen Arabi, Wilma van Bentum-Puijk, Scott Berry, Abigail Beane, Zahra Bhimani, Marc Bonten, Charlotte Bradbury, Frank Brunkhorst, Meredith Buxton, Allen Cheng, Menno De Jong, Lennie Derde, Lise Estcourt, Herman Goossens, Anthony Gordon, Cameron Green, Rashan Haniffa, Francois Lamontagne, Patrick Lawler, Edward Litton, John Marshall, Colin McArthur, Daniel McAuley, Shay McGuinness, Bryan McVerry, Stephanie Montgomery, Paul Mouncey, Srinivas Murthy, Alistair Nichol, Rachael Parke, Kathryn Rowan, Christopher Seymour, Anne Turner, Frank van de Veerdonk, Steve Webb, Ryan Zarychanski, Lewis Campbell, Andrew Forbes, David Gattas, Stephane Heritier, Lisa Higgins, Peter Kruger, Sandra Peake, Jeffrey Presneill, Ian Seppelt, Tony Trapani, Paul Young, Sean Bagshaw, Nick Daneman, Niall Ferguson, Cheryl Misak, Marlene Santos, Sebastiaan Hullegie, Mathias Pletz, Gernot Rohde, Kathy Rowan, Brian Alexander, Kim Basile, Timothy Girard, Christopher Horvat, David Huang, Kelsey Linstrum, Jennifer Vates, Richard Beasley, Robert Fowler, Steve McGloughlin, Susan Morpeth, David Paterson, Bala Venkatesh, Tim Uyeki, Kenneth Baillie, Eamon Duffy, Rob Fowler, Thomas Hills, Katrina Orr, Asad Patanwala, Steve Tong, Mihai Netea, Shilesh Bihari, Marc Carrier, Dean Fergusson, Ewan Goligher, Ghady Haidar, Beverley Hunt, Anand Kumar, Mike Laffan, Patrick Lawless, Sylvain Lother, Peter McCallum, Saskia Middeldopr, Zoe McQuilten, Matthew Neal, John Pasi, Roger Schutgens, Simon Stanworth, Alexis Turgeon, Alexandra Weissman, Neill Adhikari, Matthew Anstey, Emily Brant, Angelique de Man, Francois Lamonagne, Marie-Helene Masse, Andrew Udy, Donald Arnold, Phillipe Begin, Richard Charlewood, Michael Chasse, Mark Coyne, Jamie Cooper, James Daly, Iain Gosbell, Heli Harvala-Simmonds, Tom Hills, Sheila MacLennan, David Menon, John McDyer, Nicole Pridee, David Roberts, Manu Shankar-Hari, Helen Thomas, Alan Tinmouth, Darrell Triulzi, Tim Walsh, Erica Wood, Carolyn Calfee, Cecilia O’Kane, Murali Shyamsundar, Pratik Sinha, Taylor Thompson, Ian Young, Shailesh Bihari, Carol Hodgson, John Laffey, Danny McAuley, Neil Orford, Ary Neto, Michelle Detry, Mark Fitzgerald, Roger Lewis, Anna McGlothlin, Ashish Sanil, Christina Saunders, Lindsay Berry, Elizabeth Lorenzi, Eliza Miller, Vanessa Singh, Claire Zammit, Wilma van Bentum Puijk, Wietske Bouwman, Yara Mangindaan, Lorraine Parker, Svenja Peters, Ilse Rietveld, Kik Raymakers, Radhika Ganpat, Nicole Brillinger, Rene Markgraf, Kate Ainscough, Kathy Brickell, Aisha Anjum, Janis-Best Lane, Alvin Richards-Belle, Michelle Saull, Daisy Wiley, Julian Bion, Jason Connor, Simon Gates, Victoria Manax, Tom van der Poll, John Reynolds, Marloes van Beurden, Evelien Effelaar, Joost Schotsman, Craig Boyd, Cain Harland, Audrey Shearer, Jess Wren, Giles Clermont, William Garrard, Kyle Kalchthaler, Andrew King, Daniel Ricketts, Salim Malakoutis, Oscar Marroquin, Edvin Music, Kevin Quinn, Heidi Cate, Karen Pearson, Joanne Collins, Jane Hanson, Penny Williams, Shane Jackson, Adeeba Asghar, Sarah Dyas, Mihaela Sutu, Sheenagh Murphy, Dawn Williamson, Nhlanhla Mguni, Alison Potter, David Porter, Jayne Goodwin, Clare Rook, Susie Harrison, Hannah Williams, Hilary Campbell, Kaatje Lomme, James Williamson, Jonathan Sheffield, Willian van’t Hoff, Phobe McCracken, Meredith Young, Jasmin Board, Emma Mart, Cameron Knott, Julie Smith, Catherine Boschert, Julia Affleck, Mahesh Ramanan, Ramsy D’Souza, Kelsey Pateman, Arif Shakih, Winston Cheung, Mark Kol, Helen Wong, Asim Shah, Atul Wagh, Joanne Simpson, Graeme Duke, Peter Chan, Brittney Cartner, Stephanie Hunter, Russell Laver, Tapaswi Shrestha, Adrian Regli, Annamaria Pellicano, James McCullough, Mandy Tallott, Nikhil Kumar, Rakshit Panwar, Gail Brinkerhoff, Cassandra Koppen, Federica Cazzola, Matthew Brain, Sarah Mineall, Roy Fischer, Vishwanath Biradar, Natalie Soar, Hayden White, Kristen Estensen, Lynette Morrison, Joanne Smith, Melanie Cooper, Monash Health, Yahya Shehabi, Wisam Al-Bassam, Amanda Hulley, Christina Whitehead, Julie Lowrey, Rebecca Gresha, James Walsham, Jason Meyer, Meg Harward, Ellen Venz, Patricia Williams, Catherine Kurenda, Kirsy Smith, Margaret Smith, Rebecca Garcia, Deborah Barge, Deborah Byrne, Kathleen Byrne, Alana Driscoll, Louise Fortune, Pierre Janin, Elizabeth Yarad, Naomi Hammond, Frances Bass, Angela Ashelford, Sharon Waterson, Steve Wedd, Robert McNamara, Heidi Buhr, Jennifer Coles, Sacha Schweikert, Bradley Wibrow, Rashmi Rauniyar, Erina Myers, Ed Fysh, Ashlish Dawda, Bhaumik Mevavala, Ed Litton, Janet Ferrier, Priya Nair, Hergen Buscher, Claire Reynolds, John Santamaria, Leanne Barbazza, Jennifer Homes, Roger Smith, Lauren Murray, Jane Brailsford, Loretta Forbes, Teena Maguire, Vasanth Mariappa, Judith Smith, Scott Simpson, Matthew Maiden, Allsion Bone, Michelle Horton, Tania Salerno, Martin Sterba, Wenli Geng, Pieter Depuydt, Jan De Waele, Liesbet De Bus, Jan Fierens, Stephanie Bracke, Brenda Reeve, William Dechert, Michaël Chassé, François Martin Carrier, Dounia Boumahni, Fatna Benettaib, Ali Ghamraoui, David Bellemare, Ève Cloutier, Charles Francoeur, François Lamontagne, Frédérick D’Aragon, Elaine Carbonneau, Julie Leblond, Gloria Vazquez-Grande, Nicole Marten, Maggie Wilson, Martin Albert, Karim Serri, Alexandros Cavayas, Mathilde Duplaix, Virginie Williams, Bram Rochwerg, Tim Karachi, Simon Oczkowski, John Centofanti, Tina Millen, Erick Duan, Jennifer Tsang, Lisa Patterson, Shane English, Irene Watpool, Rebecca Porteous, Sydney Miezitis, Lauralyn McIntyre, Laurent Brochard, Karen Burns, Gyan Sandhu, Imrana Khalid, Alexandra Binnie, Elizabeth Powell, Alexandra McMillan, Tracy Luk, Noah Aref, Zdravko Andric, Sabina Cviljevic, Renata Đimoti, Marija Zapalac, Gordan Mirković, Bruno Baršić, Marko Kutleša, Viktor Kotarski, Ana Vujaklija Brajković, Jakša Babel, Helena Sever, Lidija Dragija, Ira Kušan, Suvi Vaara, Leena Pettilä, Jonna Heinonen, Anne Kuitunen, Sari Karlsson, Annukka Vahtera, Heikki Kiiski, Sanna Ristimäki, Amine Azaiz, Cyril Charron, Mathieu Godement, Guillaume Geri, Antoine Vieillard-Baron, Franck Pourcine, Mehran Monchi, David Luis, Romain Mercier, Anne Sagnier, Nathalie Verrier, Cecile Caplin, Shidasp Siami, Christelle Aparicio, Sarah Vautier, Asma Jeblaoui, Muriel Fartoukh, Laura Courtin, Vincent Labbe, Cécile Leparco, Grégoire Muller, Mai-Anh Nay, Toufik Kamel, Dalila Benzekri, Sophie Jacquier, Emmanuelle Mercier, Delphine Chartier, Charlotte Salmon, PierreFrançois Dequin, Francis Schneider, Guillaume Morel, Sylvie L’Hotellier, Julio Badie, Fernando Daniel Berdaguer, Sylvain Malfroy, Chaouki Mezher, Charlotte Bourgoin, Bruno Megarbane, Sebastian Voicu, Nicolas Deye, Isabelle Malissin, Laetitia Sutterlin, Christophe Guitton, Cédric Darreau, Mickaël Landais, Nicolas Chudeau, Alain Robert, Pierre Moine, Nicholas Heming, Virginie Maxime, Isabelle Bossard, Tiphaine Barbarin Nicholier, Gwenhael Colin, Vanessa Zinzoni, Natacham Maquigneau, André Finn, Gabriele Kreß, Uwe Hoff, Carl Friedrich Hinrichs, Jens Nee, Mathias Pletz, Stefan Hagel, Juliane Ankert, Steffi Kolanos, Frank Bloos, Sirak Petros, Bastian Pasieka, Kevin Kunz, Peter Appelt, Bianka Schütze, Stefan Kluge, Axel Nierhaus, Dominik Jarczak, Kevin Roedl, Dirk Weismann, Anna Frey, Vivantes Klinikum Neukölln, Lorenz Reill, Michael Distler, Astrid Maselli, János Bélteczki, István Magyar, Ágnes Fazekas, Sándor Kovács, Viktória Szőke, Gábor Szigligeti, János Leszkoven, Daniel Collins, Patrick Breen, Stephen Frohlich, Ruth Whelan, Bairbre McNicholas, Michael Scully, Siobhan Casey, Maeve Kernan, Peter Doran, Michael O’Dywer, Michelle Smyth, Leanne Hayes, Oscar Hoiting, Marco Peters, Els Rengers, Mirjam Evers, Anton Prinssen, Jeroen Bosch Ziekenhuis, Koen Simons, Wim Rozendaal, F Polderman, P de Jager, M Moviat, A Paling, A Salet, Emma Rademaker, Anna Linda Peters, E de Jonge, J Wigbers, E Guilder, M 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Ferguson, Katharine Sellers, Joanne Bradley-Potts, David Yates, Isobel Birkinshaw, Kay Kell, Nicola Marshall, Lisa Carr-Knott, Charlotte Summers, and Mégarbane, Bruno

Subjects
[SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, General Medicine, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Writing Committee for the REMAP-CAP Investigators, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.TOX] Life Sciences [q-bio]/Toxicology, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.TOX]Life Sciences [q-bio]/Toxicology, General & Internal Medicine, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, 11 Medical and Health Sciences
Abstract

Importance Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures The primary end point was organ support–free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned –1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support–free days were 0 (IQR, –1 to 15), 0 (IQR, –1 to 13), and 0 (–1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support–free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support–free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions.

Published
2020
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