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3. Environmental sustainability in intensive care: the path forward. An ESICM Green Paper

Author

De Waele, J, Hunfeld, N, Baid, H, Ferrer, R, Iliopoulou, K, Ioan, A, Leone, M, Ostermann, M, Scaramuzzo, G, Theodorakopoulou, M, Touw, H, Citerio, G, Derde, L, Donadello, K, Juffermans, N, Galarza, L, Grasselli, G, Maggiore, S, Martin-Loeches, I, Alexandre, J, Cecconi, M, Azoulay, E, De Waele, Jan J., Hunfeld, Nicole, Baid, Heather, Ferrer, Ricard, Iliopoulou, Katerina, Ioan, Ana-Maria, Leone, Marc, Ostermann, Marlies, Scaramuzzo, Gaetano, Theodorakopoulou, Maria, Touw, Hugo, Citerio, Giuseppe, Derde, Lennie P. G., Donadello, Katia, Juffermans, Nicole P., Galarza, Laura, Grasselli, Giacomo, Maggiore, Salvatore Maurizio, Martin-Loeches, Ignacio, Alexandre, Joel, Cecconi, Maurizio, Azoulay, Elie, De Waele, J, Hunfeld, N, Baid, H, Ferrer, R, Iliopoulou, K, Ioan, A, Leone, M, Ostermann, M, Scaramuzzo, G, Theodorakopoulou, M, Touw, H, Citerio, G, Derde, L, Donadello, K, Juffermans, N, Galarza, L, Grasselli, G, Maggiore, S, Martin-Loeches, I, Alexandre, J, Cecconi, M, Azoulay, E, De Waele, Jan J., Hunfeld, Nicole, Baid, Heather, Ferrer, Ricard, Iliopoulou, Katerina, Ioan, Ana-Maria, Leone, Marc, Ostermann, Marlies, Scaramuzzo, Gaetano, Theodorakopoulou, Maria, Touw, Hugo, Citerio, Giuseppe, Derde, Lennie P. G., Donadello, Katia, Juffermans, Nicole P., Galarza, Laura, Grasselli, Giacomo, Maggiore, Salvatore Maurizio, Martin-Loeches, Ignacio, Alexandre, Joel, Cecconi, Maurizio, and Azoulay, Elie

Abstract

Purpose: The European Society of Intensive Care Medicine (ESICM) Green Paper aims to address the challenge of environmental sustainability in intensive care and proposes actionable strategies for integrating sustainability into intensive care unit (ICU) stakeholder actions. Methods: The ESICM Executive Committee appointed a task force of topic experts and ESICM committee representatives to develop the ESICM Green Paper. The task force convened biweekly from January to June 2024, identifying key domains for environmental sustainability and prioritizing actions. Drafts were iteratively refined and approved by the ESICM Executive Committee. Results: Climate change will impact activities in intensive care in many ways, but also the impact of ICU activities on the environment is considerable; drivers for this include extensive resource use and waste generation in ICUs from energy consumption, use of disposable items, and advanced therapies for critically ill patients. The ESICM Green Paper outlines a structured approach for ICUs to reduce their environmental impact, emphasizing energy efficiency, waste reduction, and sustainable procurement. Furthermore, it endorses the need for awareness and education among healthcare professionals, integration of sustainability into research, and sustainable policies within scientific societies. Conclusions: The ESICM Green Paper reviewed the relevance of climate change to intensive care and provided suggestions for clinical practice, research, education, and ESICM organizational domains. It underscores that reducing intensive care's ecological footprint can coexist with high-quality patient care. Promoting a resilient, responsible healthcare system is a joint responsibility of all ICU stakeholders.

Published
2024

4. A guide to immunotherapy for COVID-19

Author

Veerdonk, F.L. van de, Giamarellos-Bourboulis, E., Pickkers, P., Derde, L., Leavis, H., Crevel, R. van, Engel, J.J., Wiersinga, W.J., Vlaar, A.P.J., Shankar-Hari, M., Poll, T. van der, Bonten, M., Angus, D.C., Meer, J.W.M. van der, Netea, M.G., Veerdonk, F.L. van de, Giamarellos-Bourboulis, E., Pickkers, P., Derde, L., Leavis, H., Crevel, R. van, Engel, J.J., Wiersinga, W.J., Vlaar, A.P.J., Shankar-Hari, M., Poll, T. van der, Bonten, M., Angus, D.C., Meer, J.W.M. van der, and Netea, M.G.

Abstract

Item does not contain fulltext, Immune dysregulation is an important component of the pathophysiology of COVID-19. A large body of literature has reported the effect of immune-based therapies in patients with COVID-19, with some remarkable successes such as the use of steroids or anti-cytokine therapies. However, challenges in clinical decision-making arise from the complexity of the disease phenotypes and patient heterogeneity, as well as the variable quality of evidence from immunotherapy studies. This Review aims to support clinical decision-making by providing an overview of the evidence generated by major clinical trials of host-directed therapy. We discuss patient stratification and propose an algorithm to guide the use of immunotherapy strategies in the clinic. This will not only help guide treatment decisions, but may also help to design future trials that investigate immunotherapy in other severe infections.

Published
2022

5. The European clinical research response to optimise treatment of patients with COVID-19 : lessons learned, future perspective, and recommendations

Author

Goossens, H, Derde, L, Horby, P, and Bonten, M

Subjects
Europe, Personal View, Infectious Diseases, COVID-19, Humans, Human medicine, Pandemics, Disease Outbreaks
Abstract

Clinicians have worked feverishly to treat patients with COVID-19 while also carrying out clinical research studies. We discuss how the clinical research community responded to the pandemic in Europe, what lessons were learned, and provide recommendations for future clinical research response during pandemics. We focused on two platform trials: RECOVERY and REMAP-CAP. Both trials were able to enrol patients very rapidly during the beginning of the pandemic because of pre-established structures and procedures, and because they share simple execution and flexibility to adjust when evidence emergences. However, contracting, regulatory hurdles, and competition with (often inadequately designed or underpowered) national trials was a major challenge in several EU countries. We recommend the creation of structures and partnerships that facilitate prioritisation of clinical research, simplification of clinical trial delivery, development of digital models and procedures for data collection and sharing, development of a mechanism to rapidly leverage pandemic funding and to connect EU funding with national funding, and investment in clinical trial networks, platform trials, and master protocols. Finally, the future pandemic clinical research response of the EU should be embedded in the global response. We believe that globally connected clinical trial networks will be essential to respond more effectively to future infectious diseases outbreaks.

Published
2022

6. Molecular epidemiology of MRSA in 13 ICUs from eight European countries

Author

Hetem, D. J., Derde, L. P. G., Empel, J., Mroczkowska, A., Orczykowska-Kotyna, M., Kozińska, A., Hryniewicz, W., Goossens, H., Bonten, M. J. M., Cooper, B., Malhotra-Kumar, S., Willems, R., Gniadkowski, M., Dautzenberg, M., Annane, D., Aragão, I., Chalfine, A., Dumpis, U., Esteves, F., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G., Tomic, V., Martí, A. Torres, Stammet, P., Brun-Buisson, C., Aires, E., Antoniadou, A., Armaganidis, A., Blairon, F., Carneiro, J., Chaskou, D., Coppadoro, P., Dias, A.-P., Drinovec, I., Elia, M., Exarchou, V., Flet, A., Fournier, J., Gillet, N., Jaklič, A., Jereb, M., Kane, A., Karkali, E., Kieffer, J., Kirpach, P., Landelle, C., Landercy, F., Lawrence, C., Legrand, P., Lopes, V., Magira, E., Marco, F., Martínez, J. A., Melbārde-Kelmere, A., Misset, B., Monte, R., Moreno, E., Nguyen, J. C., Novak, M., Orazi, D., Papadomichelakis, E., Papaparaskevas, J., Paris, M., Pavleas, J., Pimenta, F., Piñer, R., Radouan, A., Ramunno, M.-G., Reis, M., Rinaldi, I., Ronco, E., Jose, A. San, Seme, K., Skiada, A., Trapassi, S., Tronci, M., Verachten, M., Vila, J., Vrankar, K., Winkler, M., Zagavierou, S., Hopman, M., Leus, F., Schotsman, J., and Zwerver, J.

Published
2016
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7. Statement paper on diversity for the European Society of Intensive Care Medicine (ESICM)

Author

Weiss, Bjoern, Weiss, B., Prisco, L., Boulanger, C., Einav, S., Gruber, P., Laake, J. H., Mehta, S., Ostermann, M., Antonelli, M., Ben Nun, M., Bollen Pinto, B., Borkowska, M., Borthwick, M., Cecconi, M., Costa-Pinto, R., Derde, L. P. G., Forni, L. G., Galazzi, A., Girbes, A., Herridge, M., Hofsø, K., Juffermans, N. P., Kesecioglu, J., Lobo-Valbuena, B., Machado, F. R., Mekontso Dessap, A., Metaxa, V., Myatra, S. N., Olusanya, O., Rosenthal, M., Rygård, S. L., Schaller, S. J., Underman, K., Wade, D. M., Intensive Care Medicine, Intensive care medicine, and ACS - Diabetes & metabolism

Subjects
Male, medicine.medical_specialty, Critical Care, media_common.quotation_subject, Culture, Ethnic group, Critical Care and Intensive Care Medicine, 03 medical and health sciences, Politics, 0302 clinical medicine, Sex Factors, NOMINATE, medicine, Humans, Intensive care medicine, Society, Minority Groups, Societies, Medical, media_common, Diversity, business.industry, 030208 emergency & critical care medicine, Cultural Diversity, Identification (information), 030228 respiratory system, Socioeconomic Factors, Sexual orientation, What's New in Intensive Care, Female, Element (criminal law), Working group, business, Diversity (politics)
Abstract

Introduction Diversity has become a key-strategic element of success in various political and economic fields. The European Society of Intensive Care Medicine (ESICM) decided to make diversity a key strategic priority for the future and appointed a Task-Force on this topic. Methods In a consensus process, three Working-Groups, nominated by Task-Force members, developed statements on strategic future topics. In addition, diversity-related data available from the membership database have been analyzed and reported in aggregated form. Results The Task-Force decided to nominate working groups on (1) “sex, gender identity and sexual orientation”, (2) “ethnicity, culture and socio-economic status”, and (3) “multiprofessionalism”. These are the first prioritized topics for the near future. The first diversity-report shows targetable items in all three domains. Conclusion The diversity Task-Force defined actionable items for a one- and three-year plan that are especially aiming at the identification of potential gaps and an implementation of concrete projects for members of the ESICM. Electronic supplementary material The online version of this article (10.1007/s00134-019-05606-0) contains supplementary material, which is available to authorized users.

Published
2019
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8. Phylogenetic lineages, clones and β-lactamases in an international collection of Klebsiella oxytoca isolates non-susceptible to expanded-spectrum cephalosporins

Author

Izdebski, R., Fiett, J., Urbanowicz, P., Baraniak, A., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Brisse, S., Gniadkowski, M., Herda, M., Dautzenberg, M. J., Adler, A., Kazma, M., Navon-Venezia, S., Malhotra-Kumar, S., Lammens, C., Legrand, P., Chalfine, A., Giamarellou, H., Petrikkos, G. L., Balode, A., Dumpis, U., Stammet, P., Aragăo, I., Esteves, F., Martí, A. Torres, Lawrence, C., Salomon, J., Paul, M., Lerman, Y., Rossini, A., Salvia, A., Samso, J. Vidal, and Fierro, J.

Published
2015
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9. Survey of metallo-β-lactamase-producing Enterobacteriaceae colonizing patients in European ICUs and rehabilitation units, 2008–11

Author

Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabák, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Dautzenberg, M. J., Adler, A., Kazma, M., Navon-Venezia, S., Malhotra-Kumar, S., Lammens, C., Legrand, P., Annane, D., Chalfine, A., Giamarellou, H., Petrikkos, G. L., Nardi, G., Balode, A., Dumpis, U., Stammet, P., Arag, I., Esteves, F., Muzlovic, I., Tomic, V., Mart, A. Torres, Lawrence, C., Salomon, J., Paul, M., Lerman, Y., Rossini, A., Salvia, A., Samso, J. Vidal, and Fierro, J.

Published
2015
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11. MLST reveals potentially high-risk international clones of Enterobacter cloacae

Author

Izdebski, R., Baraniak, A., Herda, M., Fiett, J., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Derde, L. P. G., Dautzenberg, M. J., Adler, A., Kazma, M., Navon-Venezia, S., Malhotra-Kumar, S., Lammens, C., Dumpis, U., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G. L., Stammet, P., Salomon, J., Lawrence, C., Legrand, P., Rossini, A., Salvia, A., Samso, J. Vidal, Fierro, J., Paul, M., and Lerman, Y.

Published
2015
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12. The randomized embedded multifactorial adaptive platform for community-acquired pneumonia (REMAP-CAP) study: rationale and design

Author

Angus, DC, Berry, S, Lewis, RJ, Al-Beidh, F, Arabi, Y, Van Bentum-Puijk, W, Bhimani, Z, Bonten, M, Broglio, K, Brunkhorst, F, Cheng, AC, Chiche, J-D, De Jong, M, Detry, M, Goossens, H, Gordon, A, Green, C, Higgins, AM, Hullegie, SJ, Kruger, P, Lamontagne, F, Litton, E, Marshall, J, McGlothlin, A, McGuinness, S, Mouncey, P, Murthy, S, Nichol, A, O'Neill, GK, Parke, R, Parker, J, Rohde, G, Rowan, K, Turner, A, Young, P, Derde, L, McArthur, C, Webb, SA, and NIHR

Subjects
Respiratory System, 1103 Clinical Sciences
Abstract

There is broad interest in improved methods to generate robust evidence regarding best practice, especially in settings where patient conditions are heterogenous and require multiple concomitant therapies. Here, we present the rationale and design of a large, international trial that combines features of adaptive platform trials with pragmatic point-of-care trials to determine best treatment strategies for patients admitted to an intensive care unit with severe community-acquired pneumonia (CAP). The trial uses a novel design entitled a randomized embedded multifactorial adaptive platform (REMAP). The design has 5 key features: i.) randomization, allowing robust causal inference; ii.) embedding of study procedures into routine care processes, facilitating enrollment, trial efficiency, and generalizability; iii.) a multifactorial statistical model comparing multiple interventions across multiple patient subgroups; iv.) response-adaptive randomization with preferential assignment to those interventions that appear most favorable, and v.) a platform structured to permit continuous, potentially perpetual enrollment beyond the evaluation of the initial treatments. The trial randomizes patients to multiple interventions within 4 treatment domains: antibiotics, antiviral therapy for influenza, host immunomodulation with extended macrolide therapy, and alternative corticosteroid regimens, representing 240 treatment regimens. The trial generates estimates of superiority, inferiority and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection. The trial will also compare ventilatory and oxygenation strategies and has capacity to address additional questions rapidly during pandemic respiratory infections. As of January 2020, REMAP-CAP was approved and enrolling patients in 52 ICUs in 13 countries in 3 continents. In February, it transitioned into pandemic mode with several design adaptations for COVID-19 disease. Lessons learned from the design and conduct of this trial should aid in dissemination of similar platform initiatives in other disease areas. Clinical trial registered with ClinicalTrials.gov (NCT02735707)

Published
2020

13. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial

Author

Estcourt, L.J., Turgeon, A.F., McQuilten, Z.K., McVerry, B.J., Al-Beidh, F., Annane, D., Arabi, Y.M., Arnold, D.M., Beane, A., Bégin, P., Bentum-Puijk, W. van, Berry, L.R., Bhimani, Z., Birchall, J.E., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Callum, J.L., Chassé, M., Cheng, A.C., Cove, M.E., Daly, J., Derde, L., Detry, M.A., Jong, Menno de, Evans, A., Fergusson, D.A., Fish, M., Fitzgerald, M., Foley, C., Goossens, H., Gordon, A.C., Gosbell, I.B., Green, C., Haniffa, R., Harvala, H., Higgins, A.M., Hills, T.E., Hoad, V.C., Horvat, C., Huang, D.T., Hudson, C.L., Ichihara, N., Laing, E., Lamikanra, A.A., Lamontagne, F., Lawler, P.R., Linstrum, K., Litton, E., Lorenzi, E., MacLennan, S., Marshall, J., McAuley, D.F., McDyer, J.F., McGlothlin, A., McGuinness, S., Miflin, G., Montgomery, S., Mouncey, P.R., Murthy, S., Nichol, A., Parke, R., Parker, J.C., Priddee, N., Purcell, D.F.J., Reyes, L.F., Richardson, P., Robitaille, N., Rowan, K.M., Rynne, J., Saito, H., Santos, M., Saunders, C.T., Neto, A. Serpa, Seymour, C.W., Silversides, J.A., Tinmouth, A.A., Triulzi, D.J., Turner, A.M., Veerdonk, F.L. van de, Walsh, T.S., Wood, E.M., Berry, S., Lewis, R.J., Menon, D.K., McArthur, C., Zarychanski, R., Angus, D.C., Webb, S.A., Roberts, D.J., Shankar-Hari, M., Estcourt, L.J., Turgeon, A.F., McQuilten, Z.K., McVerry, B.J., Al-Beidh, F., Annane, D., Arabi, Y.M., Arnold, D.M., Beane, A., Bégin, P., Bentum-Puijk, W. van, Berry, L.R., Bhimani, Z., Birchall, J.E., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Callum, J.L., Chassé, M., Cheng, A.C., Cove, M.E., Daly, J., Derde, L., Detry, M.A., Jong, Menno de, Evans, A., Fergusson, D.A., Fish, M., Fitzgerald, M., Foley, C., Goossens, H., Gordon, A.C., Gosbell, I.B., Green, C., Haniffa, R., Harvala, H., Higgins, A.M., Hills, T.E., Hoad, V.C., Horvat, C., Huang, D.T., Hudson, C.L., Ichihara, N., Laing, E., Lamikanra, A.A., Lamontagne, F., Lawler, P.R., Linstrum, K., Litton, E., Lorenzi, E., MacLennan, S., Marshall, J., McAuley, D.F., McDyer, J.F., McGlothlin, A., McGuinness, S., Miflin, G., Montgomery, S., Mouncey, P.R., Murthy, S., Nichol, A., Parke, R., Parker, J.C., Priddee, N., Purcell, D.F.J., Reyes, L.F., Richardson, P., Robitaille, N., Rowan, K.M., Rynne, J., Saito, H., Santos, M., Saunders, C.T., Neto, A. Serpa, Seymour, C.W., Silversides, J.A., Tinmouth, A.A., Triulzi, D.J., Turner, A.M., Veerdonk, F.L. van de, Walsh, T.S., Wood, E.M., Berry, S., Lewis, R.J., Menon, D.K., McArthur, C., Zarychanski, R., Angus, D.C., Webb, S.A., Roberts, D.J., and Shankar-Hari, M.

Abstract

Item does not contain fulltext, IMPORTANCE: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. OBJECTIVE: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. INTERVENTIONS: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). MAIN OUTCOMES AND MEASURES: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromb

Published
2021

14. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients with COVID-19: A Randomized Clinical Trial.

Author

Estcourt L.J., Turgeon A.F., McQuilten Z.K., McVerry B.J., Al-Beidh F., Annane D., Arabi Y.M., Arnold D.M., Beane A., Begin P., Van Bentum-Puijk W., Berry L.R., Bhimani Z., Birchall J.E., Bonten M.J.M., Bradbury C.A., Brunkhorst F.M., Buxton M., Callum J.L., Chasse M., Cheng A.C., Cove M.E., Daly J., Derde L., Detry M.A., De Jong M., Evans A., Fergusson D.A., Fish M., Fitzgerald M., Foley C., Goossens H., Gordon A.C., Gosbell I.B., Green C., Haniffa R., Harvala H., Higgins A.M., Hills T.E., Hoad V.C., Horvat C., Huang D.T., Hudson C.L., Ichihara N., Laing E., Lamikanra A.A., Lamontagne F., Lawler P.R., Linstrum K., Litton E., Lorenzi E., Maclennan S., Marshall J., McAuley D.F., McDyer J.F., McGlothlin A., McGuinness S., Miflin G., Montgomery S., Mouncey P.R., Murthy S., Nichol A., Parke R., Parker J.C., Priddee N., Purcell D.F.J., Reyes L.F., Richardson P., Robitaille N., Rowan K.M., Rynne J., Saito H., Santos M., Saunders C.T., Serpa Neto A., Seymour C.W., Silversides J.A., Tinmouth A.A., Triulzi D.J., Turner A.M., Van De Veerdonk F., Walsh T.S., Wood E.M., Berry S., Lewis R.J., Menon D.K., McArthur C., Zarychanski R., Angus D.C., Webb S.A., Roberts D.J., Shankar-Hari M., Estcourt L.J., Turgeon A.F., McQuilten Z.K., McVerry B.J., Al-Beidh F., Annane D., Arabi Y.M., Arnold D.M., Beane A., Begin P., Van Bentum-Puijk W., Berry L.R., Bhimani Z., Birchall J.E., Bonten M.J.M., Bradbury C.A., Brunkhorst F.M., Buxton M., Callum J.L., Chasse M., Cheng A.C., Cove M.E., Daly J., Derde L., Detry M.A., De Jong M., Evans A., Fergusson D.A., Fish M., Fitzgerald M., Foley C., Goossens H., Gordon A.C., Gosbell I.B., Green C., Haniffa R., Harvala H., Higgins A.M., Hills T.E., Hoad V.C., Horvat C., Huang D.T., Hudson C.L., Ichihara N., Laing E., Lamikanra A.A., Lamontagne F., Lawler P.R., Linstrum K., Litton E., Lorenzi E., Maclennan S., Marshall J., McAuley D.F., McDyer J.F., McGlothlin A., McGuinness S., Miflin G., Montgomery S., Mouncey P.R., Murthy S., Nichol A., Parke R., Parker J.C., Priddee N., Purcell D.F.J., Reyes L.F., Richardson P., Robitaille N., Rowan K.M., Rynne J., Saito H., Santos M., Saunders C.T., Serpa Neto A., Seymour C.W., Silversides J.A., Tinmouth A.A., Triulzi D.J., Turner A.M., Van De Veerdonk F., Walsh T.S., Wood E.M., Berry S., Lewis R.J., Menon D.K., McArthur C., Zarychanski R., Angus D.C., Webb S.A., Roberts D.J., and Shankar-Hari M.

Abstract

Importance: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive. Objective(s): To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19. Design, Setting, and Participant(s): The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021. Intervention(s): The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL +/- 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916). Main Outcomes and Measures: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; veno

Published
2021

15. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update

Author

Alhazzani, W, Evans, L, Alshamsi, F, Møller, M, Ostermann, M, Prescott, H, Arabi, Y, Loeb, M, Ng Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Machado, F, Wunsch, H, Crowther, M, Cecconi, M, Koh, Y, Burry, L, Chertow, D, Szczeklik, W, Belley-Cote, E, Greco, M, Bala, M, Zarychanski, R, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Nainan Myatra, S, Arrington, A, Kleinpell, R, Citerio, G, Lewis, K, Bridges, E, Memish, Z, Hammond, N, Hayden, F, Alshahrani, M, Al Duhailib, Z, Martin, G, Kaplan, L, Coopersmith, C, Antonelli, M, Rhodes, A, Alhazzani, Waleed, Evans, Laura, Alshamsi, Fayez, Møller, Morten Hylander, Ostermann, Marlies, Prescott, Hallie C., Arabi, Yaseen M., Loeb, Mark, Ng Gong, Michelle, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Machado, Flavia, Wunsch, Hannah, Crowther, Mark, Cecconi, Maurizio, Koh, Younsuck, Burry, Lisa, Chertow, Daniel S., Szczeklik, Wojciech, Belley-Cote, Emilie, Greco, Massimiliano, Bala, Malgorzata, Zarychanski, Ryan, Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Nainan Myatra, Sheila, Arrington, Amy, Kleinpell, Ruth, Citerio, Giuseppe, Lewis, Kimberley, Bridges, Elizabeth, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Alshahrani, Muhammed, Al Duhailib, Zainab, Martin, Greg S., Kaplan, Lewis J., Coopersmith, Craig M., Antonelli, Massimo, Rhodes, Andrew, Alhazzani, W, Evans, L, Alshamsi, F, Møller, M, Ostermann, M, Prescott, H, Arabi, Y, Loeb, M, Ng Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Machado, F, Wunsch, H, Crowther, M, Cecconi, M, Koh, Y, Burry, L, Chertow, D, Szczeklik, W, Belley-Cote, E, Greco, M, Bala, M, Zarychanski, R, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Nainan Myatra, S, Arrington, A, Kleinpell, R, Citerio, G, Lewis, K, Bridges, E, Memish, Z, Hammond, N, Hayden, F, Alshahrani, M, Al Duhailib, Z, Martin, G, Kaplan, L, Coopersmith, C, Antonelli, M, Rhodes, A, Alhazzani, Waleed, Evans, Laura, Alshamsi, Fayez, Møller, Morten Hylander, Ostermann, Marlies, Prescott, Hallie C., Arabi, Yaseen M., Loeb, Mark, Ng Gong, Michelle, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Machado, Flavia, Wunsch, Hannah, Crowther, Mark, Cecconi, Maurizio, Koh, Younsuck, Burry, Lisa, Chertow, Daniel S., Szczeklik, Wojciech, Belley-Cote, Emilie, Greco, Massimiliano, Bala, Malgorzata, Zarychanski, Ryan, Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Nainan Myatra, Sheila, Arrington, Amy, Kleinpell, Ruth, Citerio, Giuseppe, Lewis, Kimberley, Bridges, Elizabeth, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Alshahrani, Muhammed, Al Duhailib, Zainab, Martin, Greg S., Kaplan, Lewis J., Coopersmith, Craig M., Antonelli, Massimo, and Rhodes, Andrew

Abstract

BACKGROUND: The coronavirus disease 2019 pandemic continues to affect millions worldwide. Given the rapidly growing evidence base, we implemented a living guideline model to provide guidance on the management of patients with severe or critical coronavirus disease 2019 in the ICU. METHODS: The Surviving Sepsis Campaign Coronavirus Disease 2019 panel has expanded to include 43 experts from 14 countries; all panel members completed an electronic conflict-of-interest disclosure form. In this update, the panel addressed nine questions relevant to managing severe or critical coronavirus disease 2019 in the ICU. We used the World Health Organization's definition of severe and critical coronavirus disease 2019. The systematic reviews team searched the literature for relevant evidence, aiming to identify systematic reviews and clinical trials. When appropriate, we performed a random-effects meta-analysis to summarize treatment effects. We assessed the quality of the evidence using the Grading of Recommendations, Assessment, Development, and Evaluation approach, then used the evidence-to-decision framework to generate recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. RESULTS: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued nine statements (three new and six updated) related to ICU patients with severe or critical coronavirus disease 2019. For severe or critical coronavirus disease 2019, the panel strongly recommends using systemic corticosteroids and venous thromboprophylaxis but strongly recommends against using hydroxychloroquine. In addition, the panel suggests using dexamethasone (compared with other corticosteroids) and suggests against using convalescent plasma and therapeutic anticoagulation outside clinical trials. The Surviving Sepsis Campaign Coronavirus Diease 2019 panel suggests using remdesivir in nonventilated patients with severe coronavirus disease 2019 and suggests again

Published
2021

20. Corrigendum to 'Personal protective equipment and intensive care unit healthcare worker safety in the COVID-19 Era (PPE-SAFE): An international survey' [Journal of Critical Care, Volume 59, October 2020, Pages 70–75] (Journal of Critical Care (2020) 59 (70–75), (S088394412030592X), (10.1016/j.jcrc.2020.06.005))

Author

Tabah, A., Ramanan, M., Laupland, K. B., Buetti, N., Cortegiani, A., Mellinghoff, J., Conway Morris, A., Camporota, L., Zappella, N., Elhadi, M., Povoa, P., Amrein, K., Vidal, G., Derde, L., Francois, G., Bassetti, M., Ssi Yan Kai, N., and De Waele, J. J.

Published
2020

21. Effect of hydrocortisone on mortality and organ support in patients with severe COVID-19: the REMAP-CAP COVID-19 corticosteroid domain randomized clinical trial

Author

Angus, DC, Derde, L, Al-Beidh, F, Annane, D, Arabi, Y, Beane, A, Van Bentum-Puijk, W, Berry, L, Bhimani, Z, Bonten, M, Bradbury, C, Brunkhorst, F, Buxton, M, Buzgau, A, Cheng, AC, De Jong, M, Detry, M, Estcourt, L, Fitzgerald, M, Goossens, H, Green, C, Haniffa, R, Higgins, AM, Horvat, C, Hullegie, SJ, Kruger, P, Lamontagne, F, Lawler, PR, Linstrum, K, Litton, E, Lorenzi, E, Marshall, J, McAuley, D, McGlothin, A, McGuinness, S, McVerry, B, Montgomery, S, Mouncey, P, Murthy, S, Nichol, A, Parke, R, Parker, J, Rowan, K, Sanil, A, Santos, M, Saunders, C, Seymour, C, Turner, A, Van De Veerdonk, F, Venkatesh, B, Zarychanski, R, Berry, S, Lewis, RJ, McArthur, C, Webb, SA, Gordon, AC, Orford, Neil, Angus, DC, Derde, L, Al-Beidh, F, Annane, D, Arabi, Y, Beane, A, Van Bentum-Puijk, W, Berry, L, Bhimani, Z, Bonten, M, Bradbury, C, Brunkhorst, F, Buxton, M, Buzgau, A, Cheng, AC, De Jong, M, Detry, M, Estcourt, L, Fitzgerald, M, Goossens, H, Green, C, Haniffa, R, Higgins, AM, Horvat, C, Hullegie, SJ, Kruger, P, Lamontagne, F, Lawler, PR, Linstrum, K, Litton, E, Lorenzi, E, Marshall, J, McAuley, D, McGlothin, A, McGuinness, S, McVerry, B, Montgomery, S, Mouncey, P, Murthy, S, Nichol, A, Parke, R, Parker, J, Rowan, K, Sanil, A, Santos, M, Saunders, C, Seymour, C, Turner, A, Van De Veerdonk, F, Venkatesh, B, Zarychanski, R, Berry, S, Lewis, RJ, McArthur, C, Webb, SA, Gordon, AC, and Orford, Neil

Published
2020

22. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19)

Author

Alhazzani, W, Møller, M, Arabi, Y, Loeb, M, Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Aboodi, M, Wunsch, H, Cecconi, M, Koh, Y, Chertow, D, Maitland, K, Alshamsi, F, Belley-Cote, E, Greco, M, Laundy, M, Morgan, J, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Alexander, P, Arrington, A, Centofanti, J, Citerio, G, Baw, B, Memish, Z, Hammond, N, Hayden, F, Evans, L, Rhodes, A, Alhazzani, Waleed, Møller, Morten Hylander, Arabi, Yaseen M., Loeb, Mark, Gong, Michelle Ng, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Aboodi, Michael, Wunsch, Hannah, Cecconi, Maurizio, Koh, Younsuck, Chertow, Daniel S., Maitland, Kathryn, Alshamsi, Fayez, Belley-Cote, Emilie, Greco, Massimiliano, Laundy, Matthew, Morgan, Jill S., Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Alexander, Paul E., Arrington, Amy, Centofanti, John E., Citerio, Giuseppe, Baw, Bandar, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Evans, Laura, Rhodes, Andrew, Alhazzani, W, Møller, M, Arabi, Y, Loeb, M, Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Aboodi, M, Wunsch, H, Cecconi, M, Koh, Y, Chertow, D, Maitland, K, Alshamsi, F, Belley-Cote, E, Greco, M, Laundy, M, Morgan, J, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Alexander, P, Arrington, A, Centofanti, J, Citerio, G, Baw, B, Memish, Z, Hammond, N, Hayden, F, Evans, L, Rhodes, A, Alhazzani, Waleed, Møller, Morten Hylander, Arabi, Yaseen M., Loeb, Mark, Gong, Michelle Ng, Fan, Eddy, Oczkowski, Simon, Levy, Mitchell M., Derde, Lennie, Dzierba, Amy, Du, Bin, Aboodi, Michael, Wunsch, Hannah, Cecconi, Maurizio, Koh, Younsuck, Chertow, Daniel S., Maitland, Kathryn, Alshamsi, Fayez, Belley-Cote, Emilie, Greco, Massimiliano, Laundy, Matthew, Morgan, Jill S., Kesecioglu, Jozef, McGeer, Allison, Mermel, Leonard, Mammen, Manoj J., Alexander, Paul E., Arrington, Amy, Centofanti, John E., Citerio, Giuseppe, Baw, Bandar, Memish, Ziad A., Hammond, Naomi, Hayden, Frederick G., Evans, Laura, and Rhodes, Andrew

Abstract

Background: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, Coronavirus Disease 2019 (COVID-19), affecting thousands of people around the world. Urgent guidance for clinicians caring for the sickest of these patients is needed. Methods: We formed a panel of 36 experts from 12 countries. All panel members completed the World Health Organization conflict of interest disclosure form. The panel proposed 53 questions that are relevant to the management of COVID-19 in the ICU. We searched the literature for direct and indirect evidence on the management of COVID-19 in critically ill patients in the ICU. We identified relevant and recent systematic reviews on most questions relating to supportive care. We assessed the certainty in the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, then generated recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. Recommendations were either strong or weak, or in the form of best practice recommendations. Results: The Surviving Sepsis Campaign COVID-19 panel issued 54 statements, of which four are best practice statements, nine are strong recommendations, and 35 are weak recommendations. No recommendation was provided for six questions. The topics were: 1) infection control, 2) laboratory diagnosis and specimens, 3) hemodynamic support, 4) ventilatory support, and 5) COVID-19 therapy. Conclusion: The Surviving Sepsis Campaign COVID-19 panel issued several recommendations to help support healthcare workers caring for critically ill ICU patients with COVID-19. When available, we will provide new evidence in further releases of these guidelines.

Published
2020

23. Molecular epidemiology of MRSA in 13 ICUs from eight European countries

Author

Landelle, Caroline, Hetem, D., Derde, L., Empel, J., Mroczkowska, A., Orczykowska-Kotyna, M., Kozińska, A., Hryniewicz, W., Goossens, H., Bonten, J., ThEMAS, Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525 (TIMC-IMAG), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP )-Centre National de la Recherche Scientifique (CNRS)-Université Joseph Fourier - Grenoble 1 (UJF)-Unité de qualitique et d'évaluation médicale - pole Santé Publique, CHU Grenoble-CHU Grenoble, Department of Microbiology, Vaccine and Infectious Disease Institute (VIDI), and University of Antwerp (UA)

Subjects
[SDV]Life Sciences [q-bio], [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2015

24. Survey of metallo-beta-lactamase-producing Enterobacteriaceae colonizing patients in European ICUs and rehabilitation units, 2008-11

Author

Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabak, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., and MOSAR WP2 WP3 WP5 Study Grp

Subjects
plasmids, PROTEUS-MIRABILIS, 1ST DETECTION, INTERNATIONAL CLONES, SEQUENCE, MBLs, ESCHERICHIA-COLI, MOLECULAR EPIDEMIOLOGY, VIM, KLEBSIELLA-PNEUMONIAE STRAINS, FIELD GEL-ELECTROPHORESIS, integrons, VIM-1, MLST
Abstract

Objectives: The objective of this study was to perform a multinational survey of patients' colonization by metallo-beta-lactamase (MBL)-producing Enterobacteriaceae, including their molecular characterization. Methods: Patients in 18 hospital units across Europe and Israel (n = 17945) were screened between mid-2008 and mid-2011. MBL-producing isolates were typed by PFGE and MLST. MBL genes were amplified and sequenced within their integrons. Plasmids with MBL genes were analysed by nuclease S1 plus hybridization profiling, mating and transformation assays, and by PCR-based replicon typing. Results: Ninety-one patients in nine centres (six countries), including 62 patients in two Greek ICUs, carried 94 non-duplicate MBL-producing organisms. Klebsiella pneumoniae isolates from Greece dominated (n = 57) and belonged mainly to ST147, ST36 and ST383. All but one of the isolates expressed VIM-1-type MBLs. Isolates of Greek origins produced five enzymes, including new VIM-39, encoded by class 1 integrons of four types. In-e541-like elements prevailed, comprising six variants located on IncR, IncFII(K), IncR+FIIK, IncR+A/C or non-typeable plasmids. The other group were new In4873 and In4863, being the first In416-like elements identified in Greece, which were present on IncA/C or non-typeable plasmids. Isolates from other countries produced only VIM-1 and the major integron was In916, identified in 16 organisms from France, Italy and Spain. In916 was carried by four plasmid types, including IncA/C, IncFII(K) and IncHI2. Other integrons included a new element, In3103, in Spain and In110 identified only in Latvia. Conclusions: This study provided fully comparable data on the occurrence and molecular characteristics of VIM-producing Enterobacteriaceae in a group of hospital units across Europe, documenting recent changes in their epidemiology.

Published
2015

25. KPC-like carbapenemase-producing enterobacteriaceae colonizing patients in Europe and Israel

Author

Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., and Gniadkowski, M.

Published
2016

26. KPC-like carbapenemase-producing enterobacteriaceae colonizing patients in Europe and Israel

Author

UMC Utrecht, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., UMC Utrecht, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P G, Bonten, M. J M, Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., and Gniadkowski, M.

Published
2016

27. Molecular epidemiology of MRSA in 13 ICUs from eight European countries

Author

MMB opleiding Arts microbioloog, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, MMB Research line 2, Epi Infectieziekten Team 1, Datamanagement 1, Hetem, D. J., Derde, L. P G, Empel, J., Mroczkowska, A., Orczykowska-Kotyna, M., Kozińska, A., Hryniewicz, W., Goossens, H., Bonten, M. J M, Cooper, B., Malhotra-Kumar, S., Willems, R., Gniadkowski, M., Dautzenberg, M., Annane, D., Aragão, I., Chalfine, A., Dumpis, U., Esteves, F., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G., Tomic, V., Torres Martí, A., Stammet, P., Brun-Buisson, C., Aires, E., Antoniadou, A., Armaganidis, A., Blairon, F., Carneiro, J., Chaskou, D., Coppadoro, P., Dias, A. P., Drinovec, I., Elia, M., Exarchou, V., Flet, A., Fournier, J., Gillet, N., Jaklič, A., Jereb, M., Kane, A., Karkali, E., Kieffer, J., Kirpach, P., Landelle, C., Landercy, F., Lawrence, C., Legrand, P., Lopes, V., Magira, E., Marco, F., Martínez, J. A., Melbarde-Kelmere, A., Misset, B., Monte, R., Moreno, E., Nguyen, J. C., Novak, M., Orazi, D., Papadomichelakis, E., Papaparaskevas, J., Paris, M., Pavleas, J., Pimenta, F., Piñer, R., Radouan, A., Ramunno, M. G., Reis, M., Rinaldi, I., Ronco, E., San Jose, A., Seme, K., Skiada, A., Trapassi, S., Tronci, M., Verachten, M., Vila, J., Vrankar, K., Winkler, M., Zagavierou, S., Hopman, M., Leus, F., Schotsman, J., Zwerver, J., MMB opleiding Arts microbioloog, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, MMB, JC onderzoeksprogramma Infectieziekten, MMB Research line 2, Epi Infectieziekten Team 1, Datamanagement 1, Hetem, D. J., Derde, L. P G, Empel, J., Mroczkowska, A., Orczykowska-Kotyna, M., Kozińska, A., Hryniewicz, W., Goossens, H., Bonten, M. J M, Cooper, B., Malhotra-Kumar, S., Willems, R., Gniadkowski, M., Dautzenberg, M., Annane, D., Aragão, I., Chalfine, A., Dumpis, U., Esteves, F., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G., Tomic, V., Torres Martí, A., Stammet, P., Brun-Buisson, C., Aires, E., Antoniadou, A., Armaganidis, A., Blairon, F., Carneiro, J., Chaskou, D., Coppadoro, P., Dias, A. P., Drinovec, I., Elia, M., Exarchou, V., Flet, A., Fournier, J., Gillet, N., Jaklič, A., Jereb, M., Kane, A., Karkali, E., Kieffer, J., Kirpach, P., Landelle, C., Landercy, F., Lawrence, C., Legrand, P., Lopes, V., Magira, E., Marco, F., Martínez, J. A., Melbarde-Kelmere, A., Misset, B., Monte, R., Moreno, E., Nguyen, J. C., Novak, M., Orazi, D., Papadomichelakis, E., Papaparaskevas, J., Paris, M., Pavleas, J., Pimenta, F., Piñer, R., Radouan, A., Ramunno, M. G., Reis, M., Rinaldi, I., Ronco, E., San Jose, A., Seme, K., Skiada, A., Trapassi, S., Tronci, M., Verachten, M., Vila, J., Vrankar, K., Winkler, M., Zagavierou, S., Hopman, M., Leus, F., Schotsman, J., and Zwerver, J.

Published
2016

30. This title is unavailable for guests, please login to see more information.

Author

MMB, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Izdebski, R., Fiett, J., Urbanowicz, P., Baraniak, A., Derde, L. P G, Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Brisse, S., Gniadkowski, M., Herda, M., Dautzenberg, M. J., Adler, A., Kazma, M., Navon-Venezia, S., Malhotra-Kumar, S., Lammens, C., Legrand, P., Chalfine, A., Giamarellou, H., Petrikkos, G. L., Balode, A., Dumpis, U., Stammet, P., Aragăo, I., Esteves, F., Torres Martí, A., Lawrence, C., Salomon, J., Paul, M., Lerman, Y., Rossini, A., Salvia, A., Vidal Samso, J., Fierro, J., MMB, MICU, Medische Staf Intensive Care, Infection & Immunity, Epi Infectieziekten, JC onderzoeksprogramma Infectieziekten, Epi Infectieziekten Team 1, Izdebski, R., Fiett, J., Urbanowicz, P., Baraniak, A., Derde, L. P G, Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Brisse, S., Gniadkowski, M., Herda, M., Dautzenberg, M. J., Adler, A., Kazma, M., Navon-Venezia, S., Malhotra-Kumar, S., Lammens, C., Legrand, P., Chalfine, A., Giamarellou, H., Petrikkos, G. L., Balode, A., Dumpis, U., Stammet, P., Aragăo, I., Esteves, F., Torres Martí, A., Lawrence, C., Salomon, J., Paul, M., Lerman, Y., Rossini, A., Salvia, A., Vidal Samso, J., and Fierro, J.

Published
2015

31. MLST reveals potentially high-risk international clones of Enterobacter cloacae

Author

Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Izdebski, R., Baraniak, A., Herda, M., Fiett, J., Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Derde, L. P G, Dautzenberg, M. J., Adler, A., Kazma, M., Navon-venezia, S., Malhotra-kumar, S., Lammens, C., Dumpis, U., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G. L., Stammet, P., Salomon, J., Lawrence, C., Legrand, P., Rossini, A., Salvia, A., Samso, J. Vidal, Fierro, J., Paul, M., Lerman, Y., Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Izdebski, R., Baraniak, A., Herda, M., Fiett, J., Bonten, M. J M, Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-buisson, C., Gniadkowski, M., Grabowska, A., Nikonorow, E., Derde, L. P G, Dautzenberg, M. J., Adler, A., Kazma, M., Navon-venezia, S., Malhotra-kumar, S., Lammens, C., Dumpis, U., Giamarellou, H., Muzlovic, I., Nardi, G., Petrikkos, G. L., Stammet, P., Salomon, J., Lawrence, C., Legrand, P., Rossini, A., Salvia, A., Samso, J. Vidal, Fierro, J., Paul, M., and Lerman, Y.

Published
2015

32. Survey of metallo-beta-lactamase-producing Enterobacteriaceae colonizing patients in European ICUs and rehabilitation units, 2008-11

Author

Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabak, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., MOSAR WP2 WP3 WP5 Study Grp, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, MMB, MICU, Medische Staf Intensive Care, Papagiannitsis, C. C., Izdebski, R., Baraniak, A., Fiett, J., Herda, M., Hrabak, J., Derde, L. P. G., Bonten, M. J. M., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., Gniadkowski, M., and MOSAR WP2 WP3 WP5 Study Grp

Published
2015

34. Phylogenetic lineages, clones and β-lactamases in an international collection ofKlebsiella oxytocaisolates non-susceptible to expanded-spectrum cephalosporins

Author

Izdebski, R., primary, Fiett, J., additional, Urbanowicz, P., additional, Baraniak, A., additional, Derde, L. P. G., additional, Bonten, M. J. M., additional, Carmeli, Y., additional, Goossens, H., additional, Hryniewicz, W., additional, Brun-Buisson, C., additional, Brisse, S., additional, and Gniadkowski, M., additional

Published
2015
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35. KPC-Like Carbapenemase-Producing EnterobacteriaceaeColonizing Patients in Europe and Israel

Author

Baraniak, A., Izdebski, R., Fiett, J., Herda, M., Derde, L. P. G., Bonten, M. J. M., Adler, A., Carmeli, Y., Goossens, H., Hryniewicz, W., Brun-Buisson, C., and Gniadkowski, M.

Abstract

ABSTRACTIn a 2008-2011 survey, 17,945 patients in 18 hospital units in Europe and Israel were screened for carriage of Klebsiella pneumoniaecarbapenemase (KPC)-producing Enterobacteriaceae, resulting in identification of 124 positive patients. The isolates were dominated by Klebsiella pneumoniaesequence type 258 (ST258) KPC-2 and ST512 KPC-3, mainly from Greece and Italy, respectively, whereas Israeli isolates were of diverse species, clones, and KPC variants. Various blaKPCplatforms were observed, among which IncFIIK-FIBKplasmids with blaKPC-2/-3genes in the Tn4401a transposon prevailed.

Published
2016
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37. Surviving Sepsis Campaign: Guidelines on the Management of Critically Ill Adults with Coronavirus Disease 2019 (COVID-19)

Author

Andrew Rhodes, Michael S. Aboodi, Eddy Fan, Waleed Alhazzani, Jill S. Morgan, Massimiliano Greco, Paul E. Alexander, Amy L. Dzierba, Lennie P. G. Derde, Mark Loeb, Maurizio Cecconi, Kathryn Maitland, Amy S. Arrington, Leonard A. Mermel, Bandar Baw, Daniel S. Chertow, Simon Oczkowski, John Centofanti, Ziad A. Memish, Michelle Ng Gong, Manoj J. Mammen, Laura Evans, Younsuck Koh, Yaseen M. Arabi, Hannah Wunsch, Bin Du, Naomi E Hammond, Frederick G Hayden, Matthew Laundy, Allison McGeer, Giuseppe Citerio, Morten Hylander Møller, Jozef Kesecioglu, Emilie P. Belley-Côté, Fayez Alshamsi, Mitchell M. Levy, Alhazzani, W, Møller, M, Arabi, Y, Loeb, M, Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Aboodi, M, Wunsch, H, Cecconi, M, Koh, Y, Chertow, D, Maitland, K, Alshamsi, F, Belley-Cote, E, Greco, M, Laundy, M, Morgan, J, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Alexander, P, Arrington, A, Centofanti, J, Citerio, G, Baw, B, Memish, Z, Hammond, N, Hayden, F, Evans, L, and Rhodes, A

Subjects
medicine.medical_specialty, Surviving Sepsis Campaign, Best practice, Coronaviru, MEDLINE, SARS CoV-2, 1110 Nursing, Critical Care and Intensive Care Medicine, 1117 Public Health and Health Services, Special Article, 03 medical and health sciences, 0302 clinical medicine, Health care, Pandemic, medicine, Infection control, Critical illne, Grading (education), Intensive care medicine, Clinical practice guideline, business.industry, Conflict of interest, COVID-19, 1103 Clinical Sciences, 030208 emergency & critical care medicine, Emergency & Critical Care Medicine, Coronavirus, COVID-19 guideline, Systematic review, 030228 respiratory system, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Clinical practice guidelines, Critical illness, business
Abstract

Supplemental Digital Content is available in the text., Background: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of a rapidly spreading illness, Coronavirus Disease 2019 (COVID-19), affecting thousands of people around the world. Urgent guidance for clinicians caring for the sickest of these patients is needed. Methods: We formed a panel of 36 experts from 12 countries. All panel members completed the World Health Organization conflict of interest disclosure form. The panel proposed 53 questions that are relevant to the management of COVID-19 in the ICU. We searched the literature for direct and indirect evidence on the management of COVID-19 in critically ill patients in the ICU. We identified relevant and recent systematic reviews on most questions relating to supportive care. We assessed the certainty in the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, then generated recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. Recommendations were either strong or weak, or in the form of best practice recommendations. Results: The Surviving Sepsis Campaign COVID-19 panel issued 54 statements, of which four are best practice statements, nine are strong recommendations, and 35 are weak recommendations. No recommendation was provided for six questions. The topics were: 1) infection control, 2) laboratory diagnosis and specimens, 3) hemodynamic support, 4) ventilatory support, and 5) COVID-19 therapy. Conclusion: The Surviving Sepsis Campaign COVID-19 panel issued several recommendations to help support healthcare workers caring for critically ill ICU patients with COVID-19. When available, we will provide new evidence in further releases of these guidelines.

Published
2020
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38. Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update

Author

Mark Crowther, Hannah Wunsch, Ryan Zarychanski, Massimo Antonelli, Daniel S. Chertow, Waleed Alhazzani, Muhammed Alshahrani, Greg S. Martin, Michelle N. Gong, Lennie P. G. Derde, Morten Hylander Møller, Frederick G. Hayden, Marlies Ostermann, Mitchell M. Levy, Wojciech Szczeklik, Younsuck Koh, Massimiliano Greco, Lisa Burry, Malgorzata M Bala, Naomi E Hammond, Simon Oczkowski, Andrew Rhodes, Bin Du, Ziad A. Memish, Laura Evans, Yaseen M. Arabi, Mark Loeb, Amy S. Arrington, Zainab Al Duhailib, Ruth M. Kleinpell, Craig M. Coopersmith, Kimberley Lewis, Lewis J. Kaplan, Amy L. Dzierba, Maurizio Cecconi, Eddy Fan, Leonard A. Mermel, Elizabeth Bridges, Giuseppe Citerio, Sheila Nainan Myatra, Flávia Ribeiro Machado, Allison McGeer, Jozef Kesecioglu, Fayez Alshamsi, Emilie P. Belley-Côté, Hallie C. Prescott, Manoj J. Mammen, Alhazzani, W, Evans, L, Alshamsi, F, Møller, M, Ostermann, M, Prescott, H, Arabi, Y, Loeb, M, Ng Gong, M, Fan, E, Oczkowski, S, Levy, M, Derde, L, Dzierba, A, Du, B, Machado, F, Wunsch, H, Crowther, M, Cecconi, M, Koh, Y, Burry, L, Chertow, D, Szczeklik, W, Belley-Cote, E, Greco, M, Bala, M, Zarychanski, R, Kesecioglu, J, Mcgeer, A, Mermel, L, Mammen, M, Nainan Myatra, S, Arrington, A, Kleinpell, R, Citerio, G, Lewis, K, Bridges, E, Memish, Z, Hammond, N, Hayden, F, Alshahrani, M, Al Duhailib, Z, Martin, G, Kaplan, L, Coopersmith, C, Antonelli, M, and Rhodes, A

Subjects
Adult, medicine.medical_specialty, Surviving Sepsis Campaign, Critical Care, Coronavirus Disease 2019 (COVID-19), Guideline, Critical Care and Intensive Care Medicine, medicine.disease_cause, Dexamethasone, Patient Positioning, 03 medical and health sciences, 0302 clinical medicine, Adrenal Cortex Hormones, Pandemic, medicine, Humans, Disease management (health), Intensive care medicine, COVID-19 Serotherapy, Coronavirus, Alanine, Evidence-Based Medicine, business.industry, Hemodynamics, Immunization, Passive, Anticoagulants, COVID-19, Disease Management, 030208 emergency & critical care medicine, Evidence-based medicine, Adenosine Monophosphate, Ventilation, Clinical trial, Intensive Care Units, Systematic review, 030228 respiratory system, Practice Guidelines as Topic, ICU, business, Hydroxychloroquine
Abstract

BACKGROUND: The coronavirus disease 2019 pandemic continues to affect millions worldwide. Given the rapidly growing evidence base, we implemented a living guideline model to provide guidance on the management of patients with severe or critical coronavirus disease 2019 in the ICU. METHODS: The Surviving Sepsis Campaign Coronavirus Disease 2019 panel has expanded to include 43 experts from 14 countries; all panel members completed an electronic conflict-of-interest disclosure form. In this update, the panel addressed nine questions relevant to managing severe or critical coronavirus disease 2019 in the ICU. We used the World Health Organization's definition of severe and critical coronavirus disease 2019. The systematic reviews team searched the literature for relevant evidence, aiming to identify systematic reviews and clinical trials. When appropriate, we performed a random-effects meta-analysis to summarize treatment effects. We assessed the quality of the evidence using the Grading of Recommendations, Assessment, Development, and Evaluation approach, then used the evidence-to-decision framework to generate recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility. RESULTS: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued nine statements (three new and six updated) related to ICU patients with severe or critical coronavirus disease 2019. For severe or critical coronavirus disease 2019, the panel strongly recommends using systemic corticosteroids and venous thromboprophylaxis but strongly recommends against using hydroxychloroquine. In addition, the panel suggests using dexamethasone (compared with other corticosteroids) and suggests against using convalescent plasma and therapeutic anticoagulation outside clinical trials. The Surviving Sepsis Campaign Coronavirus Diease 2019 panel suggests using remdesivir in nonventilated patients with severe coronavirus disease 2019 and suggests against starting remdesivir in patients with critical coronavirus disease 2019 outside clinical trials. Because of insufficient evidence, the panel did not issue a recommendation on the use of awake prone positioning. CONCLUSION: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued several recommendations to guide healthcare professionals caring for adults with critical or severe coronavirus disease 2019 in the ICU. Based on a living guideline model the recommendations will be updated as new evidence becomes available.

Published
2021
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39. The impact of the massive open online course C19_SPACE during the COVID-19 pandemic on clinical knowledge enhancement: a study among medical doctors and nurses.

Author

Cecconi M, Barth A, Szőllősi GJ, Istrate GM, Alexandre J, Duska F, Schaller SJ, Boulanger C, Mellinghoff J, Waldauf P, Girbes ARJ, Derde L, De Waele JJ, Azoulay E, and Kesecioglu J

Subjects
Humans, Female, Male, Adult, Education, Distance methods, Prospective Studies, SARS-CoV-2, Pandemics, Physicians, Nurses statistics & numerical data, Middle Aged, COVID-19 epidemiology, Clinical Competence standards, Clinical Competence statistics & numerical data
Abstract

Purpose: During the initial phase of the pandemic, healthcare professionals faced difficulties due to the limited availability of comprehensive learning resources on managing patients affected with coronavirus disease 2019 (COVID-19). The COVID-19 Skills Preparation Course (C19&#95;SPACE) was tailored to meet the overwhelming demand for specialized training. The primary objective of this study was to assess the efficacy and impact of this program on enhancing clinical knowledge and to identify factors affecting this improvement., Methods: As part of the project, data were collected prospectively to measure the baseline knowledge. After the descriptive statistics, multiple and multivariate logistic regression models were executed to identify the factors associated with knowledge increase., Results: The final sample included 3140 medical doctors (MDs) and 3090 nurses (RNs). For the primary analysis, the mean value of the baseline knowledge test score of MDs was 62.41 (standard deviation, SD = 13.48), and it significantly (p < 0.001) increased to 84.65 (SD = 11.95). Factors influencing overall knowledge scores were female sex (AOR = 1.34 [1.04-1.73]), being a specialist qualified for intensive care medicine (adjusted odds ratio, AOR = 0.56, [0.33-0.96]), and performance on the pre-test (AOR = 0.91, [0.90-0.92]). As for the RNs, the mean value of the total knowledge score was 63.25 (SD = 13.53), which significantly (p < 0.001) increased to 81.51 (SD = 14.21). Factor associated with knowledge was performance on the pre-test (AOR = 0.92 [0.92-0.93])., Conclusions: C19&#95;SPACE effectively increased the clinical knowledge of doctors and nurses. The effect was more pronounced in the program's target group of healthcare workers with less experience in the intensive care unit (ICU). Other factors associated with knowledge enhancement were sex and being a specialist in intensive care., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2024
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40. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.

Author

Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, Cheng SH, Cheng CY, Chung WS, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang YW, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo CY, Le T, Lin YC, Lin WP, Lin TH, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O'Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng TY, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong HL, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, and Hemkens LG

Published
2024
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42. ERS/ESICM/ESCMID/ALAT guidelines for the management of severe community-acquired pneumonia.

Author

Martin-Loeches I, Torres A, Nagavci B, Aliberti S, Antonelli M, Bassetti M, Bos LD, Chalmers JD, Derde L, de Waele J, Garnacho-Montero J, Kollef M, Luna CM, Menendez R, Niederman MS, Ponomarev D, Restrepo MI, Rigau D, Schultz MJ, Weiss E, Welte T, and Wunderink R

Subjects
Humans, Critical Care, Pneumonia diagnosis, Pneumonia drug therapy, Communicable Diseases
Abstract

Purpose: Severe community-acquired pneumonia (sCAP) is associated with high morbidity and mortality, and whilst European and non-European guidelines are available for community-acquired pneumonia, there are no specific guidelines for sCAP., Methods: The European Respiratory Society (ERS), European Society of Intensive Care Medicine (ESICM), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Latin American Thoracic Association (ALAT) launched a task force to develop the first international guidelines for sCAP. The panel comprised a total of 18 European and four non-European experts, as well as two methodologists. Eight clinical questions for sCAP diagnosis and treatment were chosen to be addressed. Systematic literature searches were performed in several databases. Meta-analyses were performed for evidence synthesis, whenever possible. The quality of evidence was assessed with GRADE (Grading of Recommendations, Assessment, Development and Evaluation). Evidence to Decision frameworks were used to decide on the direction and strength of recommendations., Results: Recommendations issued were related to diagnosis, antibiotics, organ support, biomarkers and co-adjuvant therapy. After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention and implications to health equity, recommendations were made for or against specific treatment interventions., Conclusions: In these international guidelines, ERS, ESICM, ESCMID, and ALAT provide evidence-based clinical practice recommendations for diagnosis, empirical treatment, and antibiotic therapy for sCAP, following the GRADE approach. Furthermore, current knowledge gaps have been highlighted and recommendations for future research have been made., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Published
2023
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43. Cohort profile of PLUTO: a perioperative biobank focusing on prediction and early diagnosis of postoperative complications.

Author

de Mul N, Verlaan D, Ruurda JP, van Grevenstein WMU, Hagendoorn J, de Borst GJ, Vriens MR, de Bree R, Zweemer RP, Vogely C, Haitsma Mulier JLG, Vernooij LM, Reitsma JB, de Zoete MR, Top J, Kluijtmans JAJ, Hoefer IE, Noordzij P, Rettig T, Marsman M, de Smet AMGA, Derde L, van Waes J, Rijsdijk M, Schellekens WJM, Bonten MJM, Slooter AJC, and Cremer OL

Subjects
Humans, Early Diagnosis, Longitudinal Studies, Postoperative Complications diagnosis, Postoperative Complications epidemiology, Biological Specimen Banks, Quality of Life
Abstract

Purpose: Although elective surgery is generally safe, some procedures remain associated with an increased risk of complications. Improved preoperative risk stratification and earlier recognition of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) cohort aims to establish a comprehensive biorepository that will facilitate research in this field. In this profile paper, we will discuss its design rationale and opportunities for future studies., Participants: Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first seven postoperative days, participants are subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel electroencephalography). Blood samples and microbiome specimens are collected at preselected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium/acute encephalopathy. Secondary outcomes include mortality and quality of life, as well as the long-term occurrence of psychopathology, cognitive dysfunction and chronic pain., Findings to Date: Enrolment of the first participant occurred early 2020. During the inception phase of the project (first 2 years), 431 patients were eligible of whom 297 patients consented to participate (69%). Observed event rate was 42% overall, with the most frequent complication being infection., Future Plans: The main purpose of the PLUTO biorepository is to provide a framework for research in the field of perioperative medicine and anaesthesiology, by storing high-quality clinical data and biomaterials for future studies. In addition, PLUTO aims to establish a logistical platform for conducting embedded clinical trials., Trial Registration Number: NCT05331118., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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44. A guide to immunotherapy for COVID-19.

Author

van de Veerdonk FL, Giamarellos-Bourboulis E, Pickkers P, Derde L, Leavis H, van Crevel R, Engel JJ, Wiersinga WJ, Vlaar APJ, Shankar-Hari M, van der Poll T, Bonten M, Angus DC, van der Meer JWM, and Netea MG

Subjects
Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Neutralizing therapeutic use, Azetidines therapeutic use, Bradykinin analogs & derivatives, Bradykinin therapeutic use, Bradykinin B2 Receptor Antagonists therapeutic use, COVID-19 immunology, Dexamethasone therapeutic use, Drug Combinations, Factor Xa Inhibitors therapeutic use, Heparin therapeutic use, Humans, Hydrocortisone therapeutic use, Imatinib Mesylate therapeutic use, Immunization, Passive, Interferon beta-1a therapeutic use, Interferon beta-1b therapeutic use, Interferon-gamma therapeutic use, Interleukin 1 Receptor Antagonist Protein therapeutic use, Kallikrein-Kinin System, Piperidines therapeutic use, Purines therapeutic use, Pyrazoles therapeutic use, Pyrimidines therapeutic use, SARS-CoV-2, Sulfonamides therapeutic use, COVID-19 Serotherapy, Anticoagulants therapeutic use, COVID-19 therapy, Complement Inactivating Agents therapeutic use, Glucocorticoids therapeutic use, Immunologic Factors therapeutic use, Immunomodulation, Protein Kinase Inhibitors therapeutic use
Abstract

Immune dysregulation is an important component of the pathophysiology of COVID-19. A large body of literature has reported the effect of immune-based therapies in patients with COVID-19, with some remarkable successes such as the use of steroids or anti-cytokine therapies. However, challenges in clinical decision-making arise from the complexity of the disease phenotypes and patient heterogeneity, as well as the variable quality of evidence from immunotherapy studies. This Review aims to support clinical decision-making by providing an overview of the evidence generated by major clinical trials of host-directed therapy. We discuss patient stratification and propose an algorithm to guide the use of immunotherapy strategies in the clinic. This will not only help guide treatment decisions, but may also help to design future trials that investigate immunotherapy in other severe infections., (© 2022. Springer Nature America, Inc.)

Published
2022
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45. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial.

Author

Estcourt LJ, Turgeon AF, McQuilten ZK, McVerry BJ, Al-Beidh F, Annane D, Arabi YM, Arnold DM, Beane A, Bégin P, van Bentum-Puijk W, Berry LR, Bhimani Z, Birchall JE, Bonten MJM, Bradbury CA, Brunkhorst FM, Buxton M, Callum JL, Chassé M, Cheng AC, Cove ME, Daly J, Derde L, Detry MA, De Jong M, Evans A, Fergusson DA, Fish M, Fitzgerald M, Foley C, Goossens H, Gordon AC, Gosbell IB, Green C, Haniffa R, Harvala H, Higgins AM, Hills TE, Hoad VC, Horvat C, Huang DT, Hudson CL, Ichihara N, Laing E, Lamikanra AA, Lamontagne F, Lawler PR, Linstrum K, Litton E, Lorenzi E, MacLennan S, Marshall J, McAuley DF, McDyer JF, McGlothlin A, McGuinness S, Miflin G, Montgomery S, Mouncey PR, Murthy S, Nichol A, Parke R, Parker JC, Priddee N, Purcell DFJ, Reyes LF, Richardson P, Robitaille N, Rowan KM, Rynne J, Saito H, Santos M, Saunders CT, Serpa Neto A, Seymour CW, Silversides JA, Tinmouth AA, Triulzi DJ, Turner AM, van de Veerdonk F, Walsh TS, Wood EM, Berry S, Lewis RJ, Menon DK, McArthur C, Zarychanski R, Angus DC, Webb SA, Roberts DJ, and Shankar-Hari M

Subjects
ABO Blood-Group System, Adult, Aged, Critical Illness therapy, Female, Hospital Mortality, Humans, Immunization, Passive, Length of Stay, Logistic Models, Male, Middle Aged, Respiration, Artificial statistics & numerical data, Treatment Failure, Vasoconstrictor Agents therapeutic use, COVID-19 Serotherapy, COVID-19 therapy
Abstract

Importance: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive., Objective: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19., Design, Setting, and Participants: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021., Interventions: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916)., Main Outcomes and Measures: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events., Results: Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group., Conclusions and Relevance: Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days., Trial Registration: ClinicalTrials.gov Identifier: NCT02735707.

Published
2021
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47. Author Correction: Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.

Author

Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, Cheng SH, Cheng CY, Chung WS, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang YW, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo CY, Le T, Lin YC, Lin WP, Lin TH, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O'Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng TY, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong HL, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, and Hemkens LG

Published
2021
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48. Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials.

Author

Axfors C, Schmitt AM, Janiaud P, Van't Hooft J, Abd-Elsalam S, Abdo EF, Abella BS, Akram J, Amaravadi RK, Angus DC, Arabi YM, Azhar S, Baden LR, Baker AW, Belkhir L, Benfield T, Berrevoets MAH, Chen CP, Chen TC, Cheng SH, Cheng CY, Chung WS, Cohen YZ, Cowan LN, Dalgard O, de Almeida E Val FF, de Lacerda MVG, de Melo GC, Derde L, Dubee V, Elfakir A, Gordon AC, Hernandez-Cardenas CM, Hills T, Hoepelman AIM, Huang YW, Igau B, Jin R, Jurado-Camacho F, Khan KS, Kremsner PG, Kreuels B, Kuo CY, Le T, Lin YC, Lin WP, Lin TH, Lyngbakken MN, McArthur C, McVerry BJ, Meza-Meneses P, Monteiro WM, Morpeth SC, Mourad A, Mulligan MJ, Murthy S, Naggie S, Narayanasamy S, Nichol A, Novack LA, O'Brien SM, Okeke NL, Perez L, Perez-Padilla R, Perrin L, Remigio-Luna A, Rivera-Martinez NE, Rockhold FW, Rodriguez-Llamazares S, Rolfe R, Rosa R, Røsjø H, Sampaio VS, Seto TB, Shahzad M, Soliman S, Stout JE, Thirion-Romero I, Troxel AB, Tseng TY, Turner NA, Ulrich RJ, Walsh SR, Webb SA, Weehuizen JM, Velinova M, Wong HL, Wrenn R, Zampieri FG, Zhong W, Moher D, Goodman SN, Ioannidis JPA, and Hemkens LG

Subjects
Adult, COVID-19 complications, COVID-19 virology, Child, Chloroquine administration & dosage, Combined Modality Therapy adverse effects, Combined Modality Therapy methods, Comorbidity, Female, Humans, Hydroxychloroquine administration & dosage, International Cooperation, Odds Ratio, Patient Participation statistics & numerical data, Pregnancy, Pregnancy Complications, Infectious drug therapy, Pregnancy Complications, Infectious virology, Randomized Controlled Trials as Topic statistics & numerical data, SARS-CoV-2, COVID-19 mortality, Chloroquine adverse effects, Hydroxychloroquine adverse effects, Pregnancy Complications, Infectious mortality, COVID-19 Drug Treatment
Abstract

Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.

Published
2021
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50. Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Author

Angus DC, Derde L, Al-Beidh F, Annane D, Arabi Y, Beane A, van Bentum-Puijk W, Berry L, Bhimani Z, Bonten M, Bradbury C, Brunkhorst F, Buxton M, Buzgau A, Cheng AC, de Jong M, Detry M, Estcourt L, Fitzgerald M, Goossens H, Green C, Haniffa R, Higgins AM, Horvat C, Hullegie SJ, Kruger P, Lamontagne F, Lawler PR, Linstrum K, Litton E, Lorenzi E, Marshall J, McAuley D, McGlothin A, McGuinness S, McVerry B, Montgomery S, Mouncey P, Murthy S, Nichol A, Parke R, Parker J, Rowan K, Sanil A, Santos M, Saunders C, Seymour C, Turner A, van de Veerdonk F, Venkatesh B, Zarychanski R, Berry S, Lewis RJ, McArthur C, Webb SA, Gordon AC, Al-Beidh F, Angus D, Annane D, Arabi Y, van Bentum-Puijk W, Berry S, Beane A, Bhimani Z, Bonten M, Bradbury C, Brunkhorst F, Buxton M, Cheng A, De Jong M, Derde L, Estcourt L, Goossens H, Gordon A, Green C, Haniffa R, Lamontagne F, Lawler P, Litton E, Marshall J, McArthur, McAuley D, McGuinness S, McVerry B, Montgomery S, Mouncey P, Murthy S, Nichol A, Parke R, Rowan K, Seymour C, Turner A, van de Veerdonk F, Webb S, Zarychanski R, Campbell L, Forbes A, Gattas D, Heritier S, Higgins L, Kruger P, Peake S, Presneill J, Seppelt I, Trapani T, Young P, Bagshaw S, Daneman N, Ferguson N, Misak C, Santos M, Hullegie S, Pletz M, Rohde G, Rowan K, Alexander B, Basile K, Girard T, Horvat C, Huang D, Linstrum K, Vates J, Beasley R, Fowler R, McGloughlin S, Morpeth S, Paterson D, Venkatesh B, Uyeki T, Baillie K, Duffy E, Fowler R, Hills T, Orr K, Patanwala A, Tong S, Netea M, Bihari S, Carrier M, Fergusson D, Goligher E, Haidar G, Hunt B, Kumar A, Laffan M, Lawless P, Lother S, McCallum P, Middeldopr S, McQuilten Z, Neal M, Pasi J, Schutgens R, Stanworth S, Turgeon A, Weissman A, Adhikari N, Anstey M, Brant E, de Man A, Lamonagne F, Masse MH, Udy A, Arnold D, Begin P, Charlewood R, Chasse M, Coyne M, Cooper J, Daly J, Gosbell I, Harvala-Simmonds H, Hills T, MacLennan S, Menon D, McDyer J, Pridee N, Roberts D, Shankar-Hari M, Thomas H, Tinmouth A, Triulzi D, Walsh T, Wood E, Calfee C, O’Kane C, Shyamsundar M, Sinha P, Thompson T, Young I, Bihari S, Hodgson C, Laffey J, McAuley D, Orford N, Neto A, Detry M, Fitzgerald M, Lewis R, McGlothlin A, Sanil A, Saunders C, Berry L, Lorenzi E, Miller E, Singh V, Zammit C, van Bentum Puijk W, Bouwman W, Mangindaan Y, Parker L, Peters S, Rietveld I, Raymakers K, Ganpat R, Brillinger N, Markgraf R, Ainscough K, Brickell K, Anjum A, Lane JB, Richards-Belle A, Saull M, Wiley D, Bion J, Connor J, Gates S, Manax V, van der Poll T, Reynolds J, van Beurden M, Effelaar E, Schotsman J, Boyd C, Harland C, Shearer A, Wren J, Clermont G, Garrard W, Kalchthaler K, King A, Ricketts D, Malakoutis S, Marroquin O, Music E, Quinn K, Cate H, Pearson K, Collins J, Hanson J, Williams P, Jackson S, Asghar A, Dyas S, Sutu M, Murphy S, Williamson D, Mguni N, Potter A, Porter D, Goodwin J, Rook C, Harrison S, Williams H, Campbell H, Lomme K, Williamson J, Sheffield J, van’t Hoff W, McCracken P, Young M, Board J, Mart E, Knott C, Smith J, Boschert C, Affleck J, Ramanan M, D’Souza R, Pateman K, Shakih A, Cheung W, Kol M, Wong H, Shah A, Wagh A, Simpson J, Duke G, Chan P, Cartner B, Hunter S, Laver R, Shrestha T, Regli A, Pellicano A, McCullough J, Tallott M, Kumar N, Panwar R, Brinkerhoff G, Koppen C, Cazzola F, Brain M, Mineall S, Fischer R, Biradar V, Soar N, White H, Estensen K, Morrison L, Smith J, Cooper M, Health M, Shehabi Y, Al-Bassam W, Hulley A, Whitehead C, Lowrey J, Gresha R, Walsham J, Meyer J, Harward M, Venz E, Williams P, Kurenda C, Smith K, Smith M, Garcia R, Barge D, Byrne D, Byrne K, Driscoll A, Fortune L, Janin P, Yarad E, Hammond N, Bass F, Ashelford A, Waterson S, Wedd S, McNamara R, Buhr H, Coles J, Schweikert S, Wibrow B, Rauniyar R, Myers E, Fysh E, Dawda A, Mevavala B, Litton E, Ferrier J, Nair P, Buscher H, Reynolds C, Santamaria J, Barbazza L, Homes J, Smith R, Murray L, Brailsford J, Forbes L, Maguire T, Mariappa V, Smith J, Simpson S, Maiden M, Bone A, Horton M, Salerno T, Sterba M, Geng W, Depuydt P, De Waele J, De Bus L, Fierens J, Bracke S, Reeve B, Dechert W, Chassé M, Carrier FM, Boumahni D, Benettaib F, Ghamraoui A, Bellemare D, Cloutier È, Francoeur C, Lamontagne F, D’Aragon F, Carbonneau E, Leblond J, Vazquez-Grande G, Marten N, Wilson, Albert M, Serri K, Cavayas A, Duplaix M, Williams V, Rochwerg B, Karachi T, Oczkowski S, Centofanti J, Millen T, Duan E, Tsang J, Patterson L, English S, Watpool I, Porteous R, Miezitis S, McIntyre L, Brochard L, Burns K, Sandhu G, Khalid I, Binnie A, Powell E, McMillan A, Luk T, Aref N, Andric Z, Cviljevic S, Đimoti R, Zapalac M, Mirković G, Baršić B, Kutleša M, Kotarski V, Vujaklija Brajković A, Babel J, Sever H, Dragija L, Kušan I, Vaara S, Pettilä L, Heinonen J, Kuitunen A, Karlsson S, Vahtera A, Kiiski H, Ristimäki S, Azaiz A, Charron C, Godement M, Geri G, Vieillard-Baron A, Pourcine F, Monchi M, Luis D, Mercier R, Sagnier A, Verrier N, Caplin C, Siami S, Aparicio C, Vautier S, Jeblaoui A, Fartoukh M, Courtin L, Labbe V, Leparco C, Muller G, Nay MA, Kamel T, Benzekri D, Jacquier S, Mercier E, Chartier D, Salmon C, Dequin P, Schneider F, Morel G, L’Hotellier S, Badie J, Berdaguer FD, Malfroy S, Mezher C, Bourgoin C, Megarbane B, Voicu, Deye N, Malissin I, Sutterlin L, Guitton C, Darreau C, Landais M, Chudeau N, Robert A, Moine P, Heming N, Maxime V, Bossard I, Nicholier TB, Colin G, Zinzoni V, Maquigneau N, Finn A, Kreß G, Hoff U, Friedrich Hinrichs C, Nee J, Pletz M, Hagel S, Ankert J, Kolanos S, Bloos F, Petros S, Pasieka B, Kunz K, Appelt P, Schütze B, Kluge S, Nierhaus A, Jarczak D, Roedl K, Weismann D, Frey A, Klinikum Neukölln V, Reill L, Distler M, Maselli A, Bélteczki J, Magyar I, Fazekas Á, Kovács S, Szőke V, Szigligeti G, Leszkoven J, Collins D, Breen P, Frohlich S, Whelan R, McNicholas B, Scully M, Casey S, Kernan M, Doran P, O’Dywer M, Smyth M, Hayes L, Hoiting O, Peters M, Rengers E, Evers M, Prinssen A, Bosch Ziekenhuis J, Simons K, Rozendaal W, Polderman F, de Jager P, Moviat M, Paling A, Salet A, Rademaker E, Peters AL, de Jonge E, Wigbers J, Guilder E, Butler M, Cowdrey KA, Newby L, Chen Y, Simmonds C, McConnochie R, Ritzema Carter J, Henderson S, Van Der Heyden K, Mehrtens J, Williams T, Kazemi A, Song R, Lai V, Girijadevi D, Everitt R, Russell R, Hacking D, Buehner U, Williams E, Browne T, Grimwade K, Goodson J, Keet O, Callender O, Martynoga R, Trask K, Butler A, Schischka L, Young C, Lesona E, Olatunji S, Robertson Y, José N, Amaro dos Santos Catorze T, de Lima Pereira TNA, Neves Pessoa LM, Castro Ferreira RM, Pereira Sousa Bastos JM, Aysel Florescu S, Stanciu D, Zaharia MF, Kosa AG, Codreanu D, Marabi Y, Al Qasim E, Moneer Hagazy M, Al Swaidan L, Arishi H, Muñoz-Bermúdez R, Marin-Corral J, Salazar Degracia A, Parrilla Gómez F, Mateo López MI, Rodriguez Fernandez J, Cárcel Fernández S, Carmona Flores R, León López R, de la Fuente Martos C, Allan A, Polgarova P, Farahi N, McWilliam S, Hawcutt D, Rad L, O’Malley L, Whitbread J, Kelsall O, Wild L, Thrush J, Wood H, Austin K, Donnelly A, Kelly M, O’Kane S, McClintock D, Warnock M, Johnston P, Gallagher LJ, Mc Goldrick C, Mc Master M, Strzelecka A, Jha R, Kalogirou M, Ellis C, Krishnamurthy V, Deelchand V, Silversides J, McGuigan P, Ward K, O’Neill A, Finn S, Phillips B, Mullan D, Oritz-Ruiz de Gordoa L, Thomas M, Sweet K, Grimmer L, Johnson R, Pinnell J, Robinson M, Gledhill L, Wood T, Morgan M, Cole J, Hill H, Davies M, Antcliffe D, Templeton M, Rojo R, Coghlan P, Smee J, Mackay E, Cort J, Whileman A, Spencer T, Spittle N, Kasipandian V, Patel A, Allibone S, Genetu RM, Ramali M, Ghosh A, Bamford P, London E, Cawley K, Faulkner M, Jeffrey H, Smith T, Brewer C, Gregory J, Limb J, Cowton A, O’Brien J, Nikitas N, Wells C, Lankester L, Pulletz M, Williams P, Birch J, Wiseman S, Horton S, Alegria A, Turki S, Elsefi T, Crisp N, Allen L, McCullagh I, Robinson P, Hays C, Babio-Galan M, Stevenson H, Khare D, Pinder M, Selvamoni S, Gopinath A, Pugh R, Menzies D, Mackay C, Allan E, Davies G, Puxty K, McCue C, Cathcart S, Hickey N, Ireland J, Yusuff H, Isgro G, Brightling C, Bourne M, Craner M, Watters M, Prout R, Davies L, Pegler S, Kyeremeh L, Arbane G, Wilson K, Gomm L, Francia F, Brett S, Sousa Arias S, Elin Hall R, Budd J, Small C, Birch J, Collins E, Henning J, Bonner S, Hugill K, Cirstea E, Wilkinson D, Karlikowski M, Sutherland H, Wilhelmsen E, Woods J, North J, Sundaran D, Hollos L, Coburn S, Walsh J, Turns M, Hopkins P, Smith J, Noble H, Depante MT, Clarey E, Laha S, Verlander M, Williams A, Huckle A, Hall A, Cooke J, Gardiner-Hill C, Maloney C, Qureshi H, Flint N, Nicholson S, Southin S, Nicholson A, Borgatta B, Turner-Bone I, Reddy A, Wilding L, Chamara Warnapura L, Agno Sathianathan R, Golden D, Hart C, Jones J, Bannard-Smith J, Henry J, Birchall K, Pomeroy F, Quayle R, Makowski A, Misztal B, Ahmed I, KyereDiabour T, Naiker K, Stewart R, Mwaura E, Mew L, Wren L, Willams F, Innes R, Doble P, Hutter J, Shovelton C, Plumb B, Szakmany T, Hamlyn V, Hawkins N, Lewis S, Dell A, Gopal S, Ganguly S, Smallwood A, Harris N, Metherell S, Lazaro JM, Newman T, Fletcher S, Nortje J, Fottrell-Gould D, Randell G, Zaman M, Elmahi E, Jones A, Hall K, Mills G, Ryalls K, Bowler H, Sall J, Bourne R, Borrill Z, Duncan T, Lamb T, Shaw J, Fox C, Moreno Cuesta J, Xavier K, Purohit D, Elhassan M, Bakthavatsalam D, Rowland M, Hutton P, Bashyal A, Davidson N, Hird C, Chhablani M, Phalod G, Kirkby A, Archer S, Netherton K, Reschreiter H, Camsooksai J, Patch S, Jenkins S, Pogson D, Rose S, Daly Z, Brimfield L, Claridge H, Parekh D, Bergin C, Bates M, Dasgin J, McGhee C, Sim M, Hay SK, Henderson S, Phull MK, Zaidi A, Pogreban T, Rosaroso LP, Harvey D, Lowe B, Meredith M, Ryan L, Hormis A, Walker R, Collier D, Kimpton S, Oakley S, Rooney K, Rodden N, Hughes E, Thomson N, McGlynn D, Walden A, Jacques N, Coles H, Tilney E, Vowell E, Schuster-Bruce M, Pitts S, Miln R, Purandare L, Vamplew L, Spivey M, Bean S, Burt K, Moore L, Day C, Gibson C, Gordon E, Zitter L, Keenan S, Baker E, Cherian S, Cutler S, Roynon-Reed A, Harrington K, Raithatha A, Bauchmuller K, Ahmad N, Grecu I, Trodd D, Martin J, Wrey Brown C, Arias AM, Craven T, Hope D, Singleton J, Clark S, Rae N, Welters I, Hamilton DO, Williams K, Waugh V, Shaw D, Puthucheary Z, Martin T, Santos F, Uddin R, Somerville A, Tatham KC, Jhanji S, Black E, Dela Rosa A, Howle R, Tully R, Drummond A, Dearden J, Philbin J, Munt S, Vuylsteke A, Chan C, Victor S, Matsa R, Gellamucho M, Creagh-Brown B, Tooley J, Montague L, De Beaux F, Bullman L, Kersiake I, Demetriou C, Mitchard S, Ramos L, White K, Donnison P, Johns M, Casey R, Mattocks L, Salisbury S, Dark P, Claxton A, McLachlan D, Slevin K, Lee S, Hulme J, Joseph S, Kinney F, Senya HJ, Oborska A, Kayani A, Hadebe B, Orath Prabakaran R, Nichols L, Thomas M, Worner R, Faulkner B, Gendall E, Hayes K, Hamilton-Davies C, Chan C, Mfuko C, Abbass H, Mandadapu V, Leaver S, Forton D, Patel K, Paramasivam E, Powell M, Gould R, Wilby E, Howcroft C, Banach D, Fernández de Pinedo Artaraz Z, Cabreros L, White I, Croft M, Holland N, Pereira R, Zaki A, Johnson D, Jackson M, Garrard H, Juhaz V, Roy A, Rostron A, Woods L, Cornell S, Pillai S, Harford R, Rees T, Ivatt H, Sundara Raman A, Davey M, Lee K, Barber R, Chablani M, Brohi F, Jagannathan V, Clark M, Purvis S, Wetherill B, Dushianthan A, Cusack R, de Courcy-Golder K, Smith S, Jackson S, Attwood B, Parsons P, Page V, Zhao XB, Oza D, Rhodes J, Anderson T, Morris S, Xia Le Tai C, Thomas A, Keen A, Digby S, Cowley N, Wild L, Southern D, Reddy H, Campbell A, Watkins C, Smuts S, Touma O, Barnes N, Alexander P, Felton T, Ferguson S, Sellers K, Bradley-Potts J, Yates D, Birkinshaw I, Kell K, Marshall N, Carr-Knott L, and Summers C

Subjects
Adrenal Cortex Hormones therapeutic use, Adult, Anti-Inflammatory Agents adverse effects, Betacoronavirus, COVID-19, Coronavirus Infections mortality, Coronavirus Infections therapy, Early Termination of Clinical Trials, Female, Humans, Hydrocortisone adverse effects, Intensive Care Units, Male, Middle Aged, Pandemics, Pneumonia, Viral mortality, Pneumonia, Viral therapy, SARS-CoV-2, Shock drug therapy, Shock etiology, Treatment Outcome, COVID-19 Drug Treatment, Anti-Inflammatory Agents administration & dosage, Coronavirus Infections drug therapy, Hydrocortisone administration & dosage, Pneumonia, Viral drug therapy, Respiration, Artificial statistics & numerical data
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., Trial Registration: ClinicalTrials.gov Identifier: NCT02735707.

Published
2020
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