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1. Long-term (180-Day) Outcomes in Critically Ill Patients With COVID-19 in the REMAP-CAP Randomized Clinical Trial.

Author

Higgins, A.M., Berry, L.R., Lorenzi, E., Murthy, S., McQuilten, Z., Mouncey, P.R., Al-Beidh, F., Annane, D., Arabi, Y.M., Beane, A., Bentum-Puijk, W. van, Bhimani, Z., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Burrell, A., Buzgau, A., Buxton, M., Charles, W.N., Cove, M., Detry, M.A., Estcourt, L.J., Fagbodun, E.O., Fitzgerald, M., Girard, T.D., Goligher, E.C., Goossens, H., Haniffa, R., Hills, T., Horvat, C.M., Huang, D.T., Ichihara, N., Lamontagne, F., Marshall, J.C., McAuley, D.F., McGlothlin, A., McGuinness, S.P., McVerry, B.J., Neal, M.D., Nichol, A.D., Parke, R.L., Parker, J.C., Parry-Billings, K., Peters, S.E.C., Reyes, L.F., Rowan, K.M., Saito, H., Santos, M.S., Saunders, C.T., Serpa-Neto, A., Seymour, C.W., Shankar-Hari, M., Stronach, L.M., Turgeon, A.F., Turner, A.M., Veerdonk, F.L. van de, Zarychanski, R., Green, C., Lewis, R.J., Angus, D.C., McArthur, C.J., Berry, S., Derde, L.P.G., Gordon, A.C., Webb, S.A., Lawler, P.R., Higgins, A.M., Berry, L.R., Lorenzi, E., Murthy, S., McQuilten, Z., Mouncey, P.R., Al-Beidh, F., Annane, D., Arabi, Y.M., Beane, A., Bentum-Puijk, W. van, Bhimani, Z., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Burrell, A., Buzgau, A., Buxton, M., Charles, W.N., Cove, M., Detry, M.A., Estcourt, L.J., Fagbodun, E.O., Fitzgerald, M., Girard, T.D., Goligher, E.C., Goossens, H., Haniffa, R., Hills, T., Horvat, C.M., Huang, D.T., Ichihara, N., Lamontagne, F., Marshall, J.C., McAuley, D.F., McGlothlin, A., McGuinness, S.P., McVerry, B.J., Neal, M.D., Nichol, A.D., Parke, R.L., Parker, J.C., Parry-Billings, K., Peters, S.E.C., Reyes, L.F., Rowan, K.M., Saito, H., Santos, M.S., Saunders, C.T., Serpa-Neto, A., Seymour, C.W., Shankar-Hari, M., Stronach, L.M., Turgeon, A.F., Turner, A.M., Veerdonk, F.L. van de, Zarychanski, R., Green, C., Lewis, R.J., Angus, D.C., McArthur, C.J., Berry, S., Derde, L.P.G., Gordon, A.C., Webb, S.A., and Lawler, P.R.

Abstract

Item does not contain fulltext, IMPORTANCE: The longer-term effects of therapies for the treatment of critically ill patients with COVID-19 are unknown. OBJECTIVE: To determine the effect of multiple interventions for critically ill adults with COVID-19 on longer-term outcomes. DESIGN, SETTING, AND PARTICIPANTS: Prespecified secondary analysis of an ongoing adaptive platform trial (REMAP-CAP) testing interventions within multiple therapeutic domains in which 4869 critically ill adult patients with COVID-19 were enrolled between March 9, 2020, and June 22, 2021, from 197 sites in 14 countries. The final 180-day follow-up was completed on March 2, 2022. INTERVENTIONS: Patients were randomized to receive 1 or more interventions within 6 treatment domains: immune modulators (n = 2274), convalescent plasma (n = 2011), antiplatelet therapy (n = 1557), anticoagulation (n = 1033), antivirals (n = 726), and corticosteroids (n = 401). MAIN OUTCOMES AND MEASURES: The main outcome was survival through day 180, analyzed using a bayesian piecewise exponential model. A hazard ratio (HR) less than 1 represented improved survival (superiority), while an HR greater than 1 represented worsened survival (harm); futility was represented by a relative improvement less than 20% in outcome, shown by an HR greater than 0.83. RESULTS: Among 4869 randomized patients (mean age, 59.3 years; 1537 [32.1%] women), 4107 (84.3%) had known vital status and 2590 (63.1%) were alive at day 180. IL-6 receptor antagonists had a greater than 99.9% probability of improving 6-month survival (adjusted HR, 0.74 [95% credible interval {CrI}, 0.61-0.90]) and antiplatelet agents had a 95% probability of improving 6-month survival (adjusted HR, 0.85 [95% CrI, 0.71-1.03]) compared with the control, while the probability of trial-defined statistical futility (HR >0.83) was high for therapeutic anticoagulation (99.9%; HR, 1.13 [95% CrI, 0.93-1.42]), convalescent plasma (99.2%; HR, 0.99 [95% CrI, 0.86-1.14]), and lopinavir-ritonavir (96.6%; HR, 1.06

Published
2023

2. Effect of Angiotensin-Converting Enzyme Inhibitor and Angiotensin Receptor Blocker Initiation on Organ Support-Free Days in Patients Hospitalized With COVID-19: A Randomized Clinical Trial.

Author

Lawler, P.R., Derde, L.P.G., Veerdonk, F.L. van de, McVerry, B.J., Huang, D.T., Berry, L.R., Lorenzi, E., Kimmenade, R.R.J. van, Gommans, F., Vaduganathan, M., Leaf, D.E., Baron, R.M., Kim, E.Y., Frankfurter, C., Epelman, S., Kwan, Y., Grieve, R., O'Neill, S., Sadique, Z., Puskarich, M., Marshall, J.C., Higgins, A.M., Mouncey, P.R., Rowan, K.M., Al-Beidh, F., Annane, D., Arabi, Y.M., Au, C., Beane, A., Bentum-Puijk, W. van, Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Burrell, A., Buzgau, A., Buxton, M., Cecconi, M., Cheng, A.C., Cove, M., Detry, M.A., Estcourt, L.J., Ezekowitz, J., Fitzgerald, M., Gattas, D., Godoy, L.C., Goossens, H., Haniffa, R., Harrison, D.A., Hills, T., Horvat, C.M., Ichihara, N., Lamontagne, F., Linstrum, K.M., McAuley, D.F., McGlothlin, A., McGuinness, S.P., McQuilten, Z., Murthy, S., Nichol, A.D., Owen, D.R.J., Parke, R.L., Parker, J.C., Pollock, K.M., Reyes, L.F., Saito, H., Santos, M.S., Saunders, C.T., Seymour, C.W., Shankar-Hari, M., Singh, V., Turgeon, A.F., Turner, A.M., Zarychanski, R., Green, C., Lewis, R.J., Angus, D.C., Berry, S., Gordon, A.C., McArthur, C.J., Webb, S.A., Lawler, P.R., Derde, L.P.G., Veerdonk, F.L. van de, McVerry, B.J., Huang, D.T., Berry, L.R., Lorenzi, E., Kimmenade, R.R.J. van, Gommans, F., Vaduganathan, M., Leaf, D.E., Baron, R.M., Kim, E.Y., Frankfurter, C., Epelman, S., Kwan, Y., Grieve, R., O'Neill, S., Sadique, Z., Puskarich, M., Marshall, J.C., Higgins, A.M., Mouncey, P.R., Rowan, K.M., Al-Beidh, F., Annane, D., Arabi, Y.M., Au, C., Beane, A., Bentum-Puijk, W. van, Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Burrell, A., Buzgau, A., Buxton, M., Cecconi, M., Cheng, A.C., Cove, M., Detry, M.A., Estcourt, L.J., Ezekowitz, J., Fitzgerald, M., Gattas, D., Godoy, L.C., Goossens, H., Haniffa, R., Harrison, D.A., Hills, T., Horvat, C.M., Ichihara, N., Lamontagne, F., Linstrum, K.M., McAuley, D.F., McGlothlin, A., McGuinness, S.P., McQuilten, Z., Murthy, S., Nichol, A.D., Owen, D.R.J., Parke, R.L., Parker, J.C., Pollock, K.M., Reyes, L.F., Saito, H., Santos, M.S., Saunders, C.T., Seymour, C.W., Shankar-Hari, M., Singh, V., Turgeon, A.F., Turner, A.M., Zarychanski, R., Green, C., Lewis, R.J., Angus, D.C., Berry, S., Gordon, A.C., McArthur, C.J., and Webb, S.A.

Abstract

Item does not contain fulltext, IMPORTANCE: Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. OBJECTIVE: To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS: In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non-critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS: Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES: The primary outcome was organ support-free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS: On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support-free days among critically ill patients was 10 (-1 to 16) in the ACE inhibitor group (n = 231), 8 (-1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support-free days compared with control were 94.9% and 95.4%, respectively. Hospital surv

Published
2023

3. Effect of Antiplatelet Therapy on Survival and Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial.

Author

Bradbury C.A., Lawler P.R., Stanworth S.J., McVerry B.J., McQuilten Z., Higgins A.M., Mouncey P.R., Al-Beidh F., Rowan K.M., Berry L.R., Lorenzi E., Zarychanski R., Arabi Y.M., Annane D., Beane A., Van Bentum-Puijk W., Bhimani Z., Bihari S., Bonten M.J.M., Brunkhorst F.M., Buzgau A., Buxton M., Carrier M., Cheng A.C., Cove M., Detry M.A., Estcourt L.J., Fitzgerald M., Girard T.D., Goligher E.C., Goossens H., Haniffa R., Hills T., Huang D.T., Horvat C.M., Hunt B.J., Ichihara N., Lamontagne F., Leavis H.L., Linstrum K.M., Litton E., Marshall J.C., McAuley D.F., McGlothlin A., McGuinness S.P., Middeldorp S., Montgomery S.K., Morpeth S.C., Murthy S., Neal M.D., Nichol A.D., Parke R.L., Parker J.C., Reyes L., Saito H., Santos M.S., Saunders C.T., Serpa-Neto A., Seymour C.W., Shankar-Hari M., Singh V., Tolppa T., Turgeon A.F., Turner A.M., Van De Veerdonk F.L., Green C., Lewis R.J., Angus D.C., McArthur C.J., Berry S., Derde L.P.G., Webb S.A., Gordon A.C., Bradbury C.A., Lawler P.R., Stanworth S.J., McVerry B.J., McQuilten Z., Higgins A.M., Mouncey P.R., Al-Beidh F., Rowan K.M., Berry L.R., Lorenzi E., Zarychanski R., Arabi Y.M., Annane D., Beane A., Van Bentum-Puijk W., Bhimani Z., Bihari S., Bonten M.J.M., Brunkhorst F.M., Buzgau A., Buxton M., Carrier M., Cheng A.C., Cove M., Detry M.A., Estcourt L.J., Fitzgerald M., Girard T.D., Goligher E.C., Goossens H., Haniffa R., Hills T., Huang D.T., Horvat C.M., Hunt B.J., Ichihara N., Lamontagne F., Leavis H.L., Linstrum K.M., Litton E., Marshall J.C., McAuley D.F., McGlothlin A., McGuinness S.P., Middeldorp S., Montgomery S.K., Morpeth S.C., Murthy S., Neal M.D., Nichol A.D., Parke R.L., Parker J.C., Reyes L., Saito H., Santos M.S., Saunders C.T., Serpa-Neto A., Seymour C.W., Shankar-Hari M., Singh V., Tolppa T., Turgeon A.F., Turner A.M., Van De Veerdonk F.L., Green C., Lewis R.J., Angus D.C., McArthur C.J., Berry S., Derde L.P.G., Webb S.A., and Gordon A.C.

Abstract

Importance: The efficacy of antiplatelet therapy in critically ill patients with COVID-19 is uncertain. Objective(s): To determine whether antiplatelet therapy improves outcomes for critically ill adults with COVID-19. Design, Setting, and Participant(s): In an ongoing adaptive platform trial (REMAP-CAP) testing multiple interventions within multiple therapeutic domains, 1557 critically ill adult patients with COVID-19 were enrolled between October 30, 2020, and June 23, 2021, from 105 sites in 8 countries and followed up for 90 days (final follow-up date: July 26, 2021). Intervention(s): Patients were randomized to receive either open-label aspirin (n = 565), a P2Y12 inhibitor (n = 455), or no antiplatelet therapy (control; n = 529). Interventions were continued in the hospital for a maximum of 14 days and were in addition to anticoagulation thromboprophylaxis. Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of intensive care unit-based respiratory or cardiovascular organ support) within 21 days, ranging from-1 for any death in hospital (censored at 90 days) to 22 for survivors with no organ support. There were 13 secondary outcomes, including survival to discharge and major bleeding to 14 days. The primary analysis was a bayesian cumulative logistic model. An odds ratio (OR) greater than 1 represented improved survival, more organ support-free days, or both. Efficacy was defined as greater than 99% posterior probability of an OR greater than 1. Futility was defined as greater than 95% posterior probability of an OR less than 1.2 vs control. Intervention equivalence was defined as greater than 90% probability that the OR (compared with each other) was between 1/1.2 and 1.2 for 2 noncontrol interventions. Result(s): The aspirin and P2Y12 inhibitor groups met the predefined criteria for equivalence at an adaptive analysis and were statistically pooled for further analysis. Enrollment was discontinued after the prespe

Published
2022

4. Effect of Antiplatelet Therapy on Survival and Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial

Author

Bradbury, C.A., Lawler, P.R., Stanworth, S.J., McVerry, B.J., McQuilten, Z., Higgins, A.M., Mouncey, P.R., Al-Beidh, F., Rowan, K.M., Berry, L.R., Lorenzi, E., Zarychanski, R., Arabi, Y.M., Annane, D., Beane, A., Bentum-Puijk, W. van, Bhimani, Z., Bihari, S., Bonten, M.J.M., Brunkhorst, F.M., Buzgau, A., Buxton, M., Carrier, M., Cheng, A.C., Cove, M., Detry, M.A., Estcourt, L.J., Fitzgerald, M., Girard, T.D., Goligher, E.C., Goossens, H., Haniffa, R., Hills, T., Huang, D.T., Horvat, C.M., Hunt, B.J., Ichihara, N., Lamontagne, F., Leavis, H.L., Linstrum, K.M., Litton, E., Marshall, J.C., McAuley, D.F., McGlothlin, A., McGuinness, S.P., Middeldorp, S., Montgomery, S.K., Morpeth, S.C., Murthy, S., Neal, M.D., Nichol, A.D., Parke, R.L., Parker, J.C., Reyes, L.F., Saito, H., Santos, M.S., Saunders, C.T., Serpa-Neto, A., Seymour, C.W., Shankar-Hari, M., Singh, V., Tolppa, T., Turgeon, A.F., Turner, A.M., Veerdonk, F.L. van de, Green, C., Lewis, R.J., Angus, D.C., McArthur, C.J., Berry, S., Derde, L.P.G., Pickkers, P., Schouten, J.A., Webb, S.A., Gordon, A.C., Bradbury, C.A., Lawler, P.R., Stanworth, S.J., McVerry, B.J., McQuilten, Z., Higgins, A.M., Mouncey, P.R., Al-Beidh, F., Rowan, K.M., Berry, L.R., Lorenzi, E., Zarychanski, R., Arabi, Y.M., Annane, D., Beane, A., Bentum-Puijk, W. van, Bhimani, Z., Bihari, S., Bonten, M.J.M., Brunkhorst, F.M., Buzgau, A., Buxton, M., Carrier, M., Cheng, A.C., Cove, M., Detry, M.A., Estcourt, L.J., Fitzgerald, M., Girard, T.D., Goligher, E.C., Goossens, H., Haniffa, R., Hills, T., Huang, D.T., Horvat, C.M., Hunt, B.J., Ichihara, N., Lamontagne, F., Leavis, H.L., Linstrum, K.M., Litton, E., Marshall, J.C., McAuley, D.F., McGlothlin, A., McGuinness, S.P., Middeldorp, S., Montgomery, S.K., Morpeth, S.C., Murthy, S., Neal, M.D., Nichol, A.D., Parke, R.L., Parker, J.C., Reyes, L.F., Saito, H., Santos, M.S., Saunders, C.T., Serpa-Neto, A., Seymour, C.W., Shankar-Hari, M., Singh, V., Tolppa, T., Turgeon, A.F., Turner, A.M., Veerdonk, F.L. van de, Green, C., Lewis, R.J., Angus, D.C., McArthur, C.J., Berry, S., Derde, L.P.G., Pickkers, P., Schouten, J.A., Webb, S.A., and Gordon, A.C.

Abstract

Item does not contain fulltext, IMPORTANCE: The efficacy of antiplatelet therapy in critically ill patients with COVID-19 is uncertain. OBJECTIVE: To determine whether antiplatelet therapy improves outcomes for critically ill adults with COVID-19. DESIGN, SETTING, AND PARTICIPANTS: In an ongoing adaptive platform trial (REMAP-CAP) testing multiple interventions within multiple therapeutic domains, 1557 critically ill adult patients with COVID-19 were enrolled between October 30, 2020, and June 23, 2021, from 105 sites in 8 countries and followed up for 90 days (final follow-up date: July 26, 2021). INTERVENTIONS: Patients were randomized to receive either open-label aspirin (n = 565), a P2Y12 inhibitor (n = 455), or no antiplatelet therapy (control; n = 529). Interventions were continued in the hospital for a maximum of 14 days and were in addition to anticoagulation thromboprophylaxis. MAIN OUTCOMES AND MEASURES: The primary end point was organ support-free days (days alive and free of intensive care unit-based respiratory or cardiovascular organ support) within 21 days, ranging from -1 for any death in hospital (censored at 90 days) to 22 for survivors with no organ support. There were 13 secondary outcomes, including survival to discharge and major bleeding to 14 days. The primary analysis was a bayesian cumulative logistic model. An odds ratio (OR) greater than 1 represented improved survival, more organ support-free days, or both. Efficacy was defined as greater than 99% posterior probability of an OR greater than 1. Futility was defined as greater than 95% posterior probability of an OR less than 1.2 vs control. Intervention equivalence was defined as greater than 90% probability that the OR (compared with each other) was between 1/1.2 and 1.2 for 2 noncontrol interventions. RESULTS: The aspirin and P2Y12 inhibitor groups met the predefined criteria for equivalence at an adaptive analysis and were statistically pooled for further analysis. Enrollment was discontinued after the prespecified c

Published
2022

5. Infection control in the intensive care unit: expert consensus statements for SARS-CoV-2 using a Delphi method

Author

Nasa, P. Azoulay, E. Chakrabarti, A. Divatia, J.V. Jain, R. Rodrigues, C. Rosenthal, V.D. Alhazzani, W. Arabi, Y.M. Bakker, J. Bassetti, M. De Waele, J. Dimopoulos, G. Du, B. Einav, S. Evans, L. Finfer, S. Guérin, C. Hammond, N.E. Jaber, S. Kleinpell, R.M. Koh, Y. Kollef, M. Levy, M.M. Machado, F.R. Mancebo, J. Martin-Loeches, I. Mer, M. Niederman, M.S. Pelosi, P. Perner, A. Peter, J.V. Phua, J. Piquilloud, L. Pletz, M.W. Rhodes, A. Schultz, M.J. Singer, M. Timsit, J.-F. Venkatesh, B. Vincent, J.-L. Welte, T. Myatra, S.N.

Abstract

During the current COVID-19 pandemic, health-care workers and uninfected patients in intensive care units (ICUs) are at risk of being infected with SARS-CoV-2 as a result of transmission from infected patients and health-care workers. In the absence of high-quality evidence on the transmission of SARS-CoV-2, clinical practice of infection control and prevention in ICUs varies widely. Using a Delphi process, international experts in intensive care, infectious diseases, and infection control developed consensus statements on infection control for SARS-CoV-2 in an ICU. Consensus was achieved for 31 (94%) of 33 statements, from which 25 clinical practice statements were issued. These statements include guidance on ICU design and engineering, health-care worker safety, visiting policy, personal protective equipment, patients and procedures, disinfection, and sterilisation. Consensus was not reached on optimal return to work criteria for health-care workers who were infected with SARS-CoV-2 or the acceptable disinfection strategy for heat-sensitive instruments used for airway management of patients with SARS-CoV-2 infection. Well designed studies are needed to assess the effects of these practice statements and address the remaining uncertainties. © 2022 Elsevier Ltd

Published
2022

6. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19

Author

Gordon, A.C., Mouncey, P.R., Al-Beidh, F., Rowan, K.M., Nichol, A.D., Arabi, Y.M., Annane, D., Beane, A., Bentum-Puijk, W. van, Berry, L.R., Bhimani, Z., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buzgau, A., Cheng, A.C., Detry, M.A., Duffy, E.J., Estcourt, L.J., Fitzgerald, M., Goossens, H., Haniffa, R., Higgins, A.M., Hills, T.E., Horvat, C.M., Lamontagne, F., Lawler, P.R., Leavis, H.L., Linstrum, K.M., Litton, E., Lorenzi, E., Marshall, J.C., Mayr, F.B., McAuley, D.F., McGlothlin, A., McGuinness, S.P., McVerry, B.J., Montgomery, S.K., Morpeth, S.C., Murthy, S., Orr, K., Parke, R.L., Parker, J.C., Patanwala, A.E., Pettilä, V., Rademaker, E., Santos, M.S., Saunders, C.T., Seymour, C.W., Shankar-Hari, M., Sligl, W.I., Turgeon, A.F., Turner, A.M., Veerdonk, F.L. van de, Zarychanski, R., Green, C., Lewis, R.J., Angus, D.C., McArthur, C.J., Berry, S., Schouten, J.A., Pickkers, P., Webb, S.A., Derde, L.P.G., Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), REMAP-CAP Investigators, Pour la France: Bruno Megarbane, Inserm U1144, European Project: 602386,EC:FP7:HEALTH,FP7-HEALTH-2013-INNOVATION-1,CREDITS4HEALTH(2013), European Project: 602525,EC:FP7:HEALTH,FP7-HEALTH-2013-INNOVATION-1,PREPARE(2014), NIHR, National Institute for Health Research, Gordon, Anthony C [0000-0002-0419-547X], Mouncey, Paul R [0000-0002-8510-8517], Beane, Abi [0000-0001-7046-1580], Bradbury, Charlotte A [0000-0001-5248-8165], Detry, Michelle A [0000-0002-2794-1439], Duffy, Eamon J [0000-0002-4515-5116], Estcourt, Lise J [0000-0003-4309-9162], Haniffa, Rashan [0000-0002-8288-449X], Higgins, Alisa M [0000-0001-8295-7559], Hills, Thomas E [0000-0003-0322-5822], Horvat, Christopher M [0000-0002-1593-2252], Lawler, Patrick R [0000-0001-5155-5071], Litton, Edward [0000-0002-5125-6829], Mayr, Florian B [0000-0002-2298-9011], McVerry, Bryan J [0000-0002-1175-4874], Patanwala, Asad E [0000-0003-3999-4703], Saunders, Christina T [0000-0003-4325-9568], Shankar-Hari, Manu [0000-0002-5338-2538], Angus, Derek C [0000-0002-7026-5181], Derde, Lennie PG [0000-0002-3577-5629], Apollo - University of Cambridge Repository, Investigators, REMAP-CAP, HAL UVSQ, Équipe, Credits-based, people-centric approach for the adoption of healthy life-styles and balanced Mediterranean diet in the frame of social participation and innovation for health promotion. - CREDITS4HEALTH - - EC:FP7:HEALTH2013-09-01 - 2016-08-31 - 602386 - VALID, and Platform foR European Preparedness Against (Re-)emerging Epidemics - PREPARE - - EC:FP7:HEALTH2014-02-01 - 2019-01-31 - 602525 - VALID

Subjects
Male, [SDV]Life Sciences [q-bio], lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, middle aged, Credible interval, Odds Ratio, odds ratio, 030212 general & internal medicine, Hospital Mortality, humans, 11 Medical and Health Sciences, adult, Hazard ratio, Covid19, General Medicine, Middle Aged, Intensive care unit, 3. Good health, [SDV] Life Sciences [q-bio], aged, Intensive Care Units, Antibodies, Monoclonal, Humanized/adverse effects, COVID-19/complications, Original Article, Female, Adult, medicine.medical_specialty, Critical Care, Critical Illness, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Tocilizumab, male, Internal medicine, General & Internal Medicine, medicine, Humans, Aged, hospital mortality, business.industry, SARS-CoV-2, COVID-19, Odds ratio, Receptors, Interleukin-6, Respiration, Artificial, COVID-19 Drug Treatment, Coronavirus, Sarilumab, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], chemistry, Receptors, Interleukin-6/antagonists & inhibitors, REMAP-CAP Investigators, interleukin-6 receptor antagonists, coronavirus disease, business
Abstract

BACKGROUNDThe efficacy of interleukin-6 receptor antagonists in critically ill patients with coronavirus disease 2019 (Covid-19) is unclear.METHODSWe evaluated tocilizumab and sarilumab in an ongoing international, multifactorial, adaptive platform trial. Adult patients with Covid-19, within 24 hours after starting organ support in the intensive care unit (ICU), were randomly assigned to receive tocilizumab (8 mg per kilogram of body weight), sarilumab (400 mg), or standard care (control). The primary outcome was respiratory and cardiovascular organ support–free days, on an ordinal scale combining in-hospital death (assigned a value of −1) and days free of organ support to day 21. The trial uses a Bayesian statistical model with predefined criteria for superiority, efficacy, equivalence, or futility. An odds ratio greater than 1 represented improved survival, more organ support–free days, or both.RESULTSBoth tocilizumab and sarilumab met the predefined criteria for efficacy. At that time, 353 patients had been assigned to tocilizumab, 48 to sarilumab, and 402 to control. The median number of organ support–free days was 10 (interquartile range, −1 to 16) in the tocilizumab group, 11 (interquartile range, 0 to 16) in the sarilumab group, and 0 (interquartile range, −1 to 15) in the control group. The median adjusted cumulative odds ratios were 1.64 (95% credible interval, 1.25 to 2.14) for tocilizumab and 1.76 (95% credible interval, 1.17 to 2.91) for sarilumab as compared with control, yielding posterior probabilities of superiority to control of more than 99.9% and of 99.5%, respectively. An analysis of 90-day survival showed improved survival in the pooled interleukin-6 receptor antagonist groups, yielding a hazard ratio for the comparison with the control group of 1.61 (95% credible interval, 1.25 to 2.08) and a posterior probability of superiority of more than 99.9%. All secondary analyses supported efficacy of these interleukin-6 receptor antagonists.CONCLUSIONSIn critically ill patients with Covid-19 receiving organ support in ICUs, treatment with the interleukin-6 receptor antagonists tocilizumab and sarilumab improved outcomes, including survival. (REMAP-CAP ClinicalTrials.gov number, NCT02735707. opens in new tab.)

Published
2021

8. 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

9. Viewpoint of a WHO Advisory Group Tasked to Consider Establishing a Closely-monitored Challenge Model of Coronavirus Disease 2019 (COVID-19) in Healthy Volunteers

Author

Levine, Myron M., Abdullah, S., Arabi, Y.M., Darko, Delese Mimi, Durbin, Anna P., Estrada, Vicente, Sauerwein, R.W., Krause, Philip R., Restrepo, A., Levine, Myron M., Abdullah, S., Arabi, Y.M., Darko, Delese Mimi, Durbin, Anna P., Estrada, Vicente, Sauerwein, R.W., Krause, Philip R., and Restrepo, A.

Abstract

Contains fulltext : 236988.pdf (Publisher’s version ) (Open Access)

Published
2021

10. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

Goligher, E.C., Bradbury, C.A., McVerry, B.J., Lawler, P.R., Berger, J.S., Gong, M.N., Carrier, M., Reynolds, H.R., Kumar, A., Turgeon, A.F., Kornblith, L.Z., Kahn, S.R., Marshall, J.C., Kim, K.S., Houston, B.L., Derde, L.P.G., Cushman, M., Tritschler, T., Angus, D.C., Godoy, L.C., McQuilten, Z., Kirwan, B.A., Farkouh, M.E., Brooks, M.M., Lewis, R.J., Berry, L.R., Lorenzi, E., Gordon, A.C., Ahuja, T., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Contreras, A., Costantini, T.W., Brouwer, S., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Eng, H.F., Escobedo, J., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Froess, J.D., Fu, Z., Galanaud, J.P., Galen, B.T., Gandotra, S., Girard, T.D., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Haniffa, R., Hegde, S.M., Hendrickson, C.M., Higgins, A.M., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Huang, D.T., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A., King, A.J., Knudson, M.M., Kornblith, A.E., Kutcher, M.E., Laffan, M.A., Lamontagne, F., Gal, G. Le, Veerdonk, F.L. van de, Middeldorp, S., Schouten, J.A., Pickkers, P., Webb, S.A., Zarychanski, R., Goligher, E.C., Bradbury, C.A., McVerry, B.J., Lawler, P.R., Berger, J.S., Gong, M.N., Carrier, M., Reynolds, H.R., Kumar, A., Turgeon, A.F., Kornblith, L.Z., Kahn, S.R., Marshall, J.C., Kim, K.S., Houston, B.L., Derde, L.P.G., Cushman, M., Tritschler, T., Angus, D.C., Godoy, L.C., McQuilten, Z., Kirwan, B.A., Farkouh, M.E., Brooks, M.M., Lewis, R.J., Berry, L.R., Lorenzi, E., Gordon, A.C., Ahuja, T., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Contreras, A., Costantini, T.W., Brouwer, S., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Eng, H.F., Escobedo, J., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Froess, J.D., Fu, Z., Galanaud, J.P., Galen, B.T., Gandotra, S., Girard, T.D., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Haniffa, R., Hegde, S.M., Hendrickson, C.M., Higgins, A.M., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Huang, D.T., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A., King, A.J., Knudson, M.M., Kornblith, A.E., Kutcher, M.E., Laffan, M.A., Lamontagne, F., Gal, G. Le, Veerdonk, F.L. van de, Middeldorp, S., Schouten, J.A., Pickkers, P., Webb, S.A., and Zarychanski, R.

Abstract

Item does not contain fulltext, BACKGROUND: Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS: In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS: The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS: In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulati

Published
2021

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

Author

Lawler, P.R., Goligher, E.C., Berger, J.S., Neal, M.D., McVerry, B.J., Nicolau, J.C., Gong, M.N., Carrier, M., Rosenson, R.S., Reynolds, H.R., Turgeon, A.F., Escobedo, J., Huang, D.T., Bradbury, C.A., Houston, B.L., Kornblith, L.Z., Kumar, A., Kahn, S.R., Cushman, M., McQuilten, Z., Slutsky, A.S., Kim, K.S., Gordon, A.C., Kirwan, B.A., Brooks, M.M., Higgins, A.M., Lewis, R.J., Lorenzi, E., Berry, S.M., Berry, L.R., Aday, A.W., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Costantini, T.W., Brouwer, S., Derde, L.P.G., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Galanaud, J.P., Galen, B.T., Gandotra, S., García-Madrona, S., Girard, T.D., Godoy, L.C., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Hamburg, N.M., Haniffa, R., Hanna, G., Hanna, N., Hegde, S.M., Hendrickson, C.M., Hite, R.D., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Iyer, V.N., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A.L., King, A.J., Knudson, M.M., Kornblith, A.E., Krishnan, V., Veerdonk, F.L. van de, Schouten, J.A., Pickkers, P., Hochman, J.S., Zarychanski, R., Lawler, P.R., Goligher, E.C., Berger, J.S., Neal, M.D., McVerry, B.J., Nicolau, J.C., Gong, M.N., Carrier, M., Rosenson, R.S., Reynolds, H.R., Turgeon, A.F., Escobedo, J., Huang, D.T., Bradbury, C.A., Houston, B.L., Kornblith, L.Z., Kumar, A., Kahn, S.R., Cushman, M., McQuilten, Z., Slutsky, A.S., Kim, K.S., Gordon, A.C., Kirwan, B.A., Brooks, M.M., Higgins, A.M., Lewis, R.J., Lorenzi, E., Berry, S.M., Berry, L.R., Aday, A.W., Al-Beidh, F., Annane, D., Arabi, Y.M., Aryal, D., Kreuziger, L. Baumann, Beane, A., Bhimani, Z., Bihari, S., Billett, H.H., Bond, L., Bonten, M., Brunkhorst, F., Buxton, M., Buzgau, A., Castellucci, L.A., Chekuri, S., Chen, J.T., Cheng, A.C., Chkhikvadze, T., Coiffard, B., Costantini, T.W., Brouwer, S., Derde, L.P.G., Detry, M.A., Duggal, A., Džavík, V., Effron, M.B., Estcourt, L.J., Everett, B.M., Fergusson, D.A., Fitzgerald, M., Fowler, R.A., Galanaud, J.P., Galen, B.T., Gandotra, S., García-Madrona, S., Girard, T.D., Godoy, L.C., Goodman, A.L., Goossens, H., Green, C., Greenstein, Y.Y., Gross, P.L., Hamburg, N.M., Haniffa, R., Hanna, G., Hanna, N., Hegde, S.M., Hendrickson, C.M., Hite, R.D., Hindenburg, A.A., Hope, A.A., Horowitz, J.M., Horvat, C.M., Hudock, K., Hunt, B.J., Husain, M., Hyzy, R.C., Iyer, V.N., Jacobson, J.R., Jayakumar, D., Keller, N.M., Khan, A., Kim, Y., Kindzelski, A.L., King, A.J., Knudson, M.M., Kornblith, A.E., Krishnan, V., Veerdonk, F.L. van de, Schouten, J.A., Pickkers, P., Hochman, J.S., and Zarychanski, R.

Abstract

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

Published
2021

12. Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial

Author

Arabi, Y.M., Gordon, A.C., Derde, L.P.G., Nichol, A.D., Murthy, S., Beidh, F.A., Annane, D., Swaidan, L.A., Beane, A., Beasley, R., Berry, L.R., Bhimani, Z., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Buzgau, A., Cheng, A., Jong, Menno de, Detry, M.A., Duffy, E.J., Estcourt, L.J., Fitzgerald, M., Fowler, R., Girard, T.D., Goligher, E.C., Goossens, H., Haniffa, R., Higgins, A.M., Hills, T.E., Horvat, C.M., Huang, D.T., King, A.J., Lamontagne, F., Lawler, P.R., Lewis, R., Linstrum, K., Litton, E., Lorenzi, E., Malakouti, S., McAuley, D.F., McGlothlin, A., McGuinness, S., McVerry, B.J., Montgomery, S.K., Morpeth, S.C., Mouncey, P.R., Orr, K., Parke, R., Parker, J.C., Patanwala, A.E., Rowan, K.M., Santos, M.S., Saunders, C.T., Seymour, C.W., Shankar-Hari, M., Tong, S.Y.C., Turgeon, A.F., Turner, A.M., Veerdonk, F.L. van de, Zarychanski, R., Green, C., Berry, S., Marshall, J.C., McArthur, C., Schouten, J.A., Angus, D.C., Webb, S.A., Arabi, Y.M., Gordon, A.C., Derde, L.P.G., Nichol, A.D., Murthy, S., Beidh, F.A., Annane, D., Swaidan, L.A., Beane, A., Beasley, R., Berry, L.R., Bhimani, Z., Bonten, M.J.M., Bradbury, C.A., Brunkhorst, F.M., Buxton, M., Buzgau, A., Cheng, A., Jong, Menno de, Detry, M.A., Duffy, E.J., Estcourt, L.J., Fitzgerald, M., Fowler, R., Girard, T.D., Goligher, E.C., Goossens, H., Haniffa, R., Higgins, A.M., Hills, T.E., Horvat, C.M., Huang, D.T., King, A.J., Lamontagne, F., Lawler, P.R., Lewis, R., Linstrum, K., Litton, E., Lorenzi, E., Malakouti, S., McAuley, D.F., McGlothlin, A., McGuinness, S., McVerry, B.J., Montgomery, S.K., Morpeth, S.C., Mouncey, P.R., Orr, K., Parke, R., Parker, J.C., Patanwala, A.E., Rowan, K.M., Santos, M.S., Saunders, C.T., Seymour, C.W., Shankar-Hari, M., Tong, S.Y.C., Turgeon, A.F., Turner, A.M., Veerdonk, F.L. van de, Zarychanski, R., Green, C., Berry, S., Marshall, J.C., McArthur, C., Schouten, J.A., Angus, D.C., and Webb, S.A.

Abstract

Item does not contain fulltext, PURPOSE: To study the efficacy of lopinavir-ritonavir and hydroxychloroquine in critically ill patients with coronavirus disease 2019 (COVID-19). METHODS: Critically ill adults with COVID-19 were randomized to receive lopinavir-ritonavir, hydroxychloroquine, combination therapy of lopinavir-ritonavir and hydroxychloroquine or no antiviral therapy (control). The primary endpoint was an ordinal scale of organ support-free days. Analyses used a Bayesian cumulative logistic model and expressed treatment effects as an adjusted odds ratio (OR) where an OR > 1 is favorable. RESULTS: We randomized 694 patients to receive lopinavir-ritonavir (n = 255), hydroxychloroquine (n = 50), combination therapy (n = 27) or control (n = 362). The median organ support-free days among patients in lopinavir-ritonavir, hydroxychloroquine, and combination therapy groups was 4 (- 1 to 15), 0 (- 1 to 9) and-1 (- 1 to 7), respectively, compared to 6 (- 1 to 16) in the control group with in-hospital mortality of 88/249 (35%), 17/49 (35%), 13/26 (50%), respectively, compared to 106/353 (30%) in the control group. The three interventions decreased organ support-free days compared to control (OR [95% credible interval]: 0.73 [0.55, 0.99], 0.57 [0.35, 0.83] 0.41 [0.24, 0.72]), yielding posterior probabilities that reached the threshold futility (≥ 99.0%), and high probabilities of harm (98.0%, 99.9% and > 99.9%, respectively). The three interventions reduced hospital survival compared with control (OR [95% CrI]: 0.65 [0.45, 0.95], 0.56 [0.30, 0.89], and 0.36 [0.17, 0.73]), yielding high probabilities of harm (98.5% and 99.4% and 99.8%, respectively). CONCLUSION: Among critically ill patients with COVID-19, lopinavir-ritonavir, hydroxychloroquine, or combination therapy worsened outcomes compared to no antiviral therapy.

Published
2021

13. Early sedation with dexmedetomidine in ventilated critically ill patients and heterogeneity of treatment effect in the SPICE III randomised controlled trial.

Author

Abidin H.Z., Hassan M.H., Omar S.C., Shukeri W.F.W., Brealey D., Bercades G., Blackburn E., Macallum N., Macklin A., Ryu J.H., Tam K., Smyth D., Arif A., Bassford C., Morgan C., Swann C., Ward G., Wild L., Bone A., Elderkin T., Green D., Sach D., Salerno T., Simpson N., Brohi F., Clark M., Williams L., Brooks J., Cocks E., Cole J., Curtin J., Davies R., Hill H., Morgan M., Palmer N., Whitton C., Wise M., Baskaran P., Hasan M.S., Tham L.Y., Cruz R.S., Dinsdale D., Edney S., Firkin C., FitzJohn F., Hill G., Hunt A., Hurford S., Jones G., Judd H., Latimer-Bell C., Lawrence C., Lesona E., Navarra L., Robertson Y., Smellie H., Vucago A.M., Young P., Dawson H., Griffith D.M., Paterson R., Clark P., Kong J., Ho J., Nayyar V., Skelly C., Shehabi Y., Serpa Neto A., Howe B.D., Arabi Y.M., Bass F.E., Kadiman S.B., McArthur C.J., Reade M.C., Seppelt I.M., Wise M.P., Mashonganyika C., McKee H., Tonks A., Donnelly A., Hemmings N., O'Kane S., Blakemore A., Butler M., Cowdrey K., Dalton J., Gilder E., Long S., McCarthy L., McGuinness S., Parke R., Chen Y., McArthur C., McConnochie R., Newby L., Bellomo R., Eastwood G., Peck L., Young H., Boschert C., Edington J., Fletcher J., Nand K., Raza A., Sara T., Bennett-Britton J., Bewley J., Bodenham V., Cole L., Driver K., Grimmer L., Howie L., Searles C., Sweet K., Webster D., van Berkel A., Connor H., Dennett J., van Der Graaff M., Henderson S., Mehrtens J., Miller K., Minto E., Morris A., Noble S., Parker K., Hart N., Shepherd K., Vij S., Dickson S., Elloway E., Ferguson C., Jackson R., MacNaughton P., Marner M., Squire R., Waddy S., Wafer P., Welbourne J., Ashcroft P., Chambler D., Dukes S., Harris A., Horton S., Sharpe S., Williams P., Williams S., Bailey M., Blazquez E., France D., Hutchison R., Comadira G., Gough M., Tallott M., Bastick M., Cameron R., Donovan S., Gaur A., Gregory R., Naumoff J., Turner E., White M., Au K.F.J., Fratzia J., Treloar S., Lim C.H., Maseeda Y., Tan A.P., Tang C.L., Yong C.Y., Akaltan M., Berger S., Blaser D., Fazlija L., Jong M.L., Lensch M., Ludwig R., Merz T., Nettelbeck K., Roth M., Schafer M., Takala J., Wehr A., Zacharias D., Amran R., Ashraf H.N., Azmi N., Basri N., Burhanuddin H., Hadinata Y., Hamdan A., Kadiman S., Rashid A.I.Y.M., Sabran I.N., Sulaiman S., Zabidi I.N., Al-Dawood A., Aljuaid M., Al Anizi H., Al Saeedi A., Arabi Y., Dbsawy M., Deeb A., Hegazy M., Magdi I., Corcoran E., Finney C., Dumlao L.A., Bassam R., Hassan M.A., Naseem N., Al-Kurdi M.H., Al-Harthy A.M., Bernard S., Sebafundi L., Serban C., Lim S.K., Mazidah N., Saidin N., Sjamsuddin N., Tan I.T.A., Zabidi N., Brain M., Mineall S., Kanhere M., Soar N., Kadir N.A., Abdullah N.H., Awang R., Emperan Z., Husin N.S., Ismail N.I., Ismail S.Z., Khadzali F.N.A.M., Norddin M.F., Aguila J., Bold C., Clatworthy B., Dias A., Hogan C., Kazemi A., Lai V., Song R., Williams A., Bhatia D., Bulfin L., Elliot S., Galt P., Lavrans K., Ritchie P., Wang A., Gresham R., Lowrey J., Masters K., Palejs P., Seppelt I., Symonds F., Weisbrodt L., Whitehead C., Babio-Galan M., Calder V., Clement I., Harrison A., McCullagh I., Scott C., Bevan R., Caniba S., Hacking D., Maher L., Azzolini M.L., Beccaria P., Colombo S., Landoni G., Leggieri C., Luca C., Mamo D., Moizo E., Monti G., Mucci M., Zangrillo A., Albania M., Arora S., Shi Y., Abudayah A., Almekhlafi G., Al Amodi E., Al Samarrai S., Badawi M., Caba R.C., Elffaki O., Mandourah Y., Valerio J., Joyce C., Meyer J., Saylor E., Venkatesh B., Venz E., Walsham J., Wetzig K., Clarey E., Harris C., Hopkins P., Noble H., Thompson L., Williams T., Khoo T.M., Liew J.E.S., Sakthi A.N., Zulkurnain A., Bamford A., Bergin C., Carrera R., Cooper L., Despy L., Ellis K., Harkett S., Mee L., Reeves E., Snelson C., Spruce E., Cooper G., Hodgson R., Pearson D., Rosbergen M., Ali M.N., Bahar N.I., Ismail A., Ismail W.N.W., Samat N.M., Piah N.S.M., Rahman R.A., Duroux M., Ratcliffe M., Warhurst T., Buehner U., Williams E., Jacques N., Keating L., Macgill S., Tamang K.L., Tolan N., Walden A., Bower R., Cranshaw J., Molloy K., Pitts S., Butler J., Dunlop R., Fourie C., Jarrett P., Lassig-Smith M., Livermore A., O'Donoghue S., Reade M., Starr T., Stuart J., Campbell L., Phillips M., Stephens D., Thomas J., Cooper D., McAllister R., Andrew G., Barclay L., Hope D., Wojcik G., McCulloch C., Ascough L., Paisley C., Patrick-Heselton J., Shaw D., Waugh V., Williams K., Welters I., Barge D., Jordan A., MacIsaac C., Rechnitzer T., Bass F., Gatward J., Hammond N., Janin P., O'Connor A., Stedman W., Yarad E., Razak N.A., Dzulkipli N., Jong S.L., Asen K., Voon W.L., Liew S., Ball J., Barnes V., Dalton C., Farnell-Ward S., Farrah H., Maher K., Mellinghoff J., Ryan C., Shirley P., Conlon L., Glover A., Martin-Loeches I., O'Toole E., Ewan J., Ferrier J., Litton E., Webb S.A., Berry W., Alonso U.B., Bociek A., Campos S., Jawara S., Hanks F., Kelly A., Lei K., McKenzie C., Ostermann M., Wan R., Al-Soufi S., Leow S., McCann K., Reynolds C., Brickell K., Fahey C., Hays L., Hyde N., Nichol A., Ryan D., Brailsford J., Buckley A., Forbes L., Maguire T., Moore J., Murray L., Ghosh A., Park M., Said S., Smith J., Visser A., Ali S., Abidin H.Z., Hassan M.H., Omar S.C., Shukeri W.F.W., Brealey D., Bercades G., Blackburn E., Macallum N., Macklin A., Ryu J.H., Tam K., Smyth D., Arif A., Bassford C., Morgan C., Swann C., Ward G., Wild L., Bone A., Elderkin T., Green D., Sach D., Salerno T., Simpson N., Brohi F., Clark M., Williams L., Brooks J., Cocks E., Cole J., Curtin J., Davies R., Hill H., Morgan M., Palmer N., Whitton C., Wise M., Baskaran P., Hasan M.S., Tham L.Y., Cruz R.S., Dinsdale D., Edney S., Firkin C., FitzJohn F., Hill G., Hunt A., Hurford S., Jones G., Judd H., Latimer-Bell C., Lawrence C., Lesona E., Navarra L., Robertson Y., Smellie H., Vucago A.M., Young P., Dawson H., Griffith D.M., Paterson R., Clark P., Kong J., Ho J., Nayyar V., Skelly C., Shehabi Y., Serpa Neto A., Howe B.D., Arabi Y.M., Bass F.E., Kadiman S.B., McArthur C.J., Reade M.C., Seppelt I.M., Wise M.P., Mashonganyika C., McKee H., Tonks A., Donnelly A., Hemmings N., O'Kane S., Blakemore A., Butler M., Cowdrey K., Dalton J., Gilder E., Long S., McCarthy L., McGuinness S., Parke R., Chen Y., McArthur C., McConnochie R., Newby L., Bellomo R., Eastwood G., Peck L., Young H., Boschert C., Edington J., Fletcher J., Nand K., Raza A., Sara T., Bennett-Britton J., Bewley J., Bodenham V., Cole L., Driver K., Grimmer L., Howie L., Searles C., Sweet K., Webster D., van Berkel A., Connor H., Dennett J., van Der Graaff M., Henderson S., Mehrtens J., Miller K., Minto E., Morris A., Noble S., Parker K., Hart N., Shepherd K., Vij S., Dickson S., Elloway E., Ferguson C., Jackson R., MacNaughton P., Marner M., Squire R., Waddy S., Wafer P., Welbourne J., Ashcroft P., Chambler D., Dukes S., Harris A., Horton S., Sharpe S., Williams P., Williams S., Bailey M., Blazquez E., France D., Hutchison R., Comadira G., Gough M., Tallott M., Bastick M., Cameron R., Donovan S., Gaur A., Gregory R., Naumoff J., Turner E., White M., Au K.F.J., Fratzia J., Treloar S., Lim C.H., Maseeda Y., Tan A.P., Tang C.L., Yong C.Y., Akaltan M., Berger S., Blaser D., Fazlija L., Jong M.L., Lensch M., Ludwig R., Merz T., Nettelbeck K., Roth M., Schafer M., Takala J., Wehr A., Zacharias D., Amran R., Ashraf H.N., Azmi N., Basri N., Burhanuddin H., Hadinata Y., Hamdan A., Kadiman S., Rashid A.I.Y.M., Sabran I.N., Sulaiman S., Zabidi I.N., Al-Dawood A., Aljuaid M., Al Anizi H., Al Saeedi A., Arabi Y., Dbsawy M., Deeb A., Hegazy M., Magdi I., Corcoran E., Finney C., Dumlao L.A., Bassam R., Hassan M.A., Naseem N., Al-Kurdi M.H., Al-Harthy A.M., Bernard S., Sebafundi L., Serban C., Lim S.K., Mazidah N., Saidin N., Sjamsuddin N., Tan I.T.A., Zabidi N., Brain M., Mineall S., Kanhere M., Soar N., Kadir N.A., Abdullah N.H., Awang R., Emperan Z., Husin N.S., Ismail N.I., Ismail S.Z., Khadzali F.N.A.M., Norddin M.F., Aguila J., Bold C., Clatworthy B., Dias A., Hogan C., Kazemi A., Lai V., Song R., Williams A., Bhatia D., Bulfin L., Elliot S., Galt P., Lavrans K., Ritchie P., Wang A., Gresham R., Lowrey J., Masters K., Palejs P., Seppelt I., Symonds F., Weisbrodt L., Whitehead C., Babio-Galan M., Calder V., Clement I., Harrison A., McCullagh I., Scott C., Bevan R., Caniba S., Hacking D., Maher L., Azzolini M.L., Beccaria P., Colombo S., Landoni G., Leggieri C., Luca C., Mamo D., Moizo E., Monti G., Mucci M., Zangrillo A., Albania M., Arora S., Shi Y., Abudayah A., Almekhlafi G., Al Amodi E., Al Samarrai S., Badawi M., Caba R.C., Elffaki O., Mandourah Y., Valerio J., Joyce C., Meyer J., Saylor E., Venkatesh B., Venz E., Walsham J., Wetzig K., Clarey E., Harris C., Hopkins P., Noble H., Thompson L., Williams T., Khoo T.M., Liew J.E.S., Sakthi A.N., Zulkurnain A., Bamford A., Bergin C., Carrera R., Cooper L., Despy L., Ellis K., Harkett S., Mee L., Reeves E., Snelson C., Spruce E., Cooper G., Hodgson R., Pearson D., Rosbergen M., Ali M.N., Bahar N.I., Ismail A., Ismail W.N.W., Samat N.M., Piah N.S.M., Rahman R.A., Duroux M., Ratcliffe M., Warhurst T., Buehner U., Williams E., Jacques N., Keating L., Macgill S., Tamang K.L., Tolan N., Walden A., Bower R., Cranshaw J., Molloy K., Pitts S., Butler J., Dunlop R., Fourie C., Jarrett P., Lassig-Smith M., Livermore A., O'Donoghue S., Reade M., Starr T., Stuart J., Campbell L., Phillips M., Stephens D., Thomas J., Cooper D., McAllister R., Andrew G., Barclay L., Hope D., Wojcik G., McCulloch C., Ascough L., Paisley C., Patrick-Heselton J., Shaw D., Waugh V., Williams K., Welters I., Barge D., Jordan A., MacIsaac C., Rechnitzer T., Bass F., Gatward J., Hammond N., Janin P., O'Connor A., Stedman W., Yarad E., Razak N.A., Dzulkipli N., Jong S.L., Asen K., Voon W.L., Liew S., Ball J., Barnes V., Dalton C., Farnell-Ward S., Farrah H., Maher K., Mellinghoff J., Ryan C., Shirley P., Conlon L., Glover A., Martin-Loeches I., O'Toole E., Ewan J., Ferrier J., Litton E., Webb S.A., Berry W., Alonso U.B., Bociek A., Campos S., Jawara S., Hanks F., Kelly A., Lei K., McKenzie C., Ostermann M., Wan R., Al-Soufi S., Leow S., McCann K., Reynolds C., Brickell K., Fahey C., Hays L., Hyde N., Nichol A., Ryan D., Brailsford J., Buckley A., Forbes L., Maguire T., Moore J., Murray L., Ghosh A., Park M., Said S., Smith J., Visser A., and Ali S.

Abstract

Purpose: To quantify potential heterogeneity of treatment effect (HTE), of early sedation with dexmedetomidine (DEX) compared with usual care, and identify patients who have a high probability of lower or higher 90-day mortality according to age, and other identified clusters. Method(s): Bayesian analysis of 3904 critically ill adult patients expected to receive invasive ventilation > 24 h and enrolled in a multinational randomized controlled trial comparing early DEX with usual care sedation. Result(s): HTE was assessed according to age and clusters (based on 12 baseline characteristics) using a Bayesian hierarchical models. DEX was associated with lower 90-day mortality compared to usual care in patients > 65 years (odds ratio [OR], 0.83 [95% credible interval [CrI] 0.68-1.00], with 97.7% probability of reduced mortality across broad categories of illness severity. Conversely, the probability of increased mortality in patients = 65 years was 98.5% (OR 1.26 [95% CrI 1.02-1.56]. Two clusters were identified: cluster 1 (976 patients) mostly operative, and cluster 2 (2346 patients), predominantly non-operative. There was a greater probability of benefit with DEX in cluster 1 (OR 0.86 [95% CrI 0.65-1.14]) across broad categories of age, with 86.4% probability that DEX is more beneficial in cluster 1 than cluster 2. Conclusion(s): In critically ill mechanically ventilated patients, early sedation with dexmedetomidine exhibited a high probability of reduced 90-day mortality in older patients regardless of operative or non-operative cluster status. Conversely, a high probability of increased 90-day mortality was observed in younger patients of non-operative status. Further studies are needed to confirm these findings.Copyright © 2021, Crown.

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

16. Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) randomised clinical trial: Study protocol.

Author

Shehabi Y., Muscedere J., Parke R., Reynolds S., Rogers B., Fowler R.A., Daneman N., Rishu A.H., Pinto R.L., Arabi Y.M., Cook D.J., Hall R., McGuinness S., Shehabi Y., Muscedere J., Parke R., Reynolds S., Rogers B., Fowler R.A., Daneman N., Rishu A.H., Pinto R.L., Arabi Y.M., Cook D.J., Hall R., and McGuinness S.

Abstract

Introduction Bloodstream infections are a leading cause of mortality and morbidity; the duration of treatment for these infections is understudied. Methods and analysis We will conduct an international, multicentre randomised clinical trial of shorter (7 days) versus longer (14 days) antibiotic treatment among hospitalised patients with bloodstream infections. The trial will include 3626 patients across 60 hospitals and 6 countries. We will include patients with blood cultures confirming a pathogenic bacterium after hospital admission. Exclusion criteria will include patient factors (severe immunosuppression), infection site factors (endocarditis, osteomyelitis, undrained abscesses, infected prosthetic material) and pathogen factors (Staphylococcus aureus, Staphylococcus lugdunensis, Candida and contaminant organisms). We will leave the selection of specific antibiotics, doses and route of delivery to the discretion of treating physicians; no placebo control will be used given the diversity of pathogens and sources of bacteraemia. The intervention will be assignment of treatment duration to be 7 versus 14 days. We will minimise selection bias via central randomisation with variable block sizes, with concealed allocation until day 7 of adequate antibiotic treatment. The primary outcome is 90-day survival; we will test whether 7 days is non-inferior to 14 days of treatment, with a non-inferiority margin of 4% absolute mortality. Secondary outcomes include hospital and intensive care unit (ICU) mortality, relapse rates of bacteraemia, hospital and ICU length of stay, mechanical ventilation and vasopressor duration, antibiotic-free days, Clostridium difficile infection, antibiotic allergy and adverse events and colonisation/infection with antibiotic-resistant organisms. Ethics and dissemination The study has been approved by the ethics review board at each participating site. Sunnybrook Health Sciences Centre is the central ethics committee. We will disseminate study re

Published
2020

17. Association between minimum inhibitory concentration, beta-lactamase genes and mortality for patients treated with piperacillin/tazobactam or meropenem from the MERINO study.

Author

Beatson S.A., Cottrell K.K., Bauer M.J., Tan E., Chaw K., Nimmo G.R., Harris-Brown T., Harris P.N.A., Boyles T.H., Looke D.F.M., Runnegar N.J., Miyakis S., Walls G., Ai Khamis M., Zikri A., Crowe A., Ingram P.R., Daneman N.N., Griffin P., Athan E., Peleg A.Y., Roberts L., Henderson A., Paterson D.L., Chatfield M.D., Tambyah P.A., Lye D.C., De P.P., Lin R.T.P., Chew K.L., Yin M., Lee T.H., Yilmaz M., Cakmak R., Alenazi T.H., Arabi Y.M., Falcone M., Bassetti M., Righi E., Ba R., Kanj S.S., Bhally H., Iredell J., Mendelson M., Beatson S.A., Cottrell K.K., Bauer M.J., Tan E., Chaw K., Nimmo G.R., Harris-Brown T., Harris P.N.A., Boyles T.H., Looke D.F.M., Runnegar N.J., Miyakis S., Walls G., Ai Khamis M., Zikri A., Crowe A., Ingram P.R., Daneman N.N., Griffin P., Athan E., Peleg A.Y., Roberts L., Henderson A., Paterson D.L., Chatfield M.D., Tambyah P.A., Lye D.C., De P.P., Lin R.T.P., Chew K.L., Yin M., Lee T.H., Yilmaz M., Cakmak R., Alenazi T.H., Arabi Y.M., Falcone M., Bassetti M., Righi E., Ba R., Kanj S.S., Bhally H., Iredell J., and Mendelson M.

Abstract

INTRODUCTION: This study aims to assess the association of piperacillin/tazobactam and meropenem minimum inhibitory concentration (MIC) and beta-lactam resistance genes with mortality in the MERINO trial. METHOD(S): Blood culture isolates from enrolled patients were tested by broth microdilution and whole genome sequencing at a central laboratory. Multivariate logistic regression was performed to account for confounders. Absolute risk increase for 30-day mortality between treatment groups was calculated for the primary analysis (PA) and the microbiologic assessable (MA) populations. RESULT(S): 320 isolates from 379 enrolled patients were available with susceptibility to piperacillin/tazobactam 94% and meropenem 100%. The piperacillin/tazobactam non-susceptible breakpoint (MIC > 16 mg/L) best predicted 30-day mortality after accounting for confounders (odds ratio 14.9, 95% CI 2.8 - 87.2). The absolute risk increase for 30-day mortality for patients treated with piperacillin/tazobactam compared with meropenem was 9% (95% CI 3% - 15%) and 8% (95% CI 2% - 15%) for the original PA population and the post-hoc MA populations, which reduced to 5% (95% CI -1% - 10%) after excluding strains with piperacillin/tazobactam MIC values > 16 mg/L. Isolates co-harboring ESBL and OXA-1 genes were associated with elevated piperacillin/tazobactam MICs and the highest risk increase in 30-mortality of 14% (95% CI 2% - 28%). CONCLUSION(S): After excluding non-susceptible strains, the 30-day mortality difference was from the MERINO trial was less pronounced for piperacillin/tazobactam. Poor reliability in susceptibility testing performance for piperacillin/tazobactam and the high prevalence of OXA co-harboring ESBLs suggests meropenem remains the preferred choice for definitive treatment of ceftriaxone non-susceptible E. coli and Klebsiella.Copyright © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permission

Published
2020

18. The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: A subgroup analysis of the Sedation Practice in Intensive Care Evaluation [SPICE III] Trial.

Author

Webb S.A., Cioccari L., Luethi N., Bailey M., Messmer A.S., Proimos H.K., Peck L., Young H., Eastwood G.M., Merz T.M., Jakob S.M., Arabi Y., Erickson S., Shehabi Y., Howe B., Bellomo R., Arabi Y.M., Bass F., Kadiman S., McArthur C., Reade M., Seppelt I., Takala J., Wise M.P., Bailey M.J., Howe B.D., Murray L., Singh V., Webb S.A., Cioccari L., Luethi N., Bailey M., Messmer A.S., Proimos H.K., Peck L., Young H., Eastwood G.M., Merz T.M., Jakob S.M., Arabi Y., Erickson S., Shehabi Y., Howe B., Bellomo R., Arabi Y.M., Bass F., Kadiman S., McArthur C., Reade M., Seppelt I., Takala J., Wise M.P., Bailey M.J., Howe B.D., Murray L., and Singh V.

Abstract

Background: Septic shock is associated with decreased vasopressor responsiveness. Experimental data suggest that central alpha2-agonists like dexmedetomidine (DEX) increase vasopressor responsiveness and reduce catecholamine requirements in septic shock. However, DEX may also cause hypotension and bradycardia. Thus, it remains unclear whether DEX is hemodynamically safe or helpful in this setting. Method(s): In this post hoc subgroup analysis of the Sedation Practice in Intensive Care Evaluation (SPICE III) trial, an international randomized trial comparing early sedation with dexmedetomidine to usual care in critically patients receiving mechanical ventilation, we studied patients with septic shock admitted to two tertiary ICUs in Australia and Switzerland. The primary outcome was vasopressor requirements in the first 48 h after randomization, expressed as noradrenaline equivalent dose (NEq [mug/kg/min] = noradrenaline + adrenaline + vasopressin/0.4). Result(s): Between November 2013 and February 2018, 417 patients were recruited into the SPICE III trial at both sites. Eighty-three patients with septic shock were included in this subgroup analysis. Of these, 44 (53%) received DEX and 39 (47%) usual care. Vasopressor requirements in the first 48 h were similar between the two groups. Median NEq dose was 0.03 [0.01, 0.07] mug/kg/min in the DEX group and 0.04 [0.01, 0.16] mug/kg/min in the usual care group (p = 0.17). However, patients in the DEX group had a lower NEq/MAP ratio, indicating lower vasopressor requirements to maintain the target MAP. Moreover, on adjusted multivariable analysis, higher dexmedetomidine dose was associated with a lower NEq/MAP ratio. Conclusion(s): In critically ill patients with septic shock, patients in the DEX group received similar vasopressor doses in the first 48 h compared to the usual care group. On multivariable adjusted analysis, dexmedetomidine appeared to be associated with lower vasopressor requirements to maintain the target

Published
2020

19. Patient Outcomes at Twelve Months after Early Decompressive Craniectomy for Diffuse Traumatic Brain Injury in the Randomized DECRA Clinical Trial

Author

Cooper, D.J. (D. James), Rosenfeld, J.V. (Jeffrey V.), Murray, L. (Lynnette), Arabi, Y.M. (Yaseen M.), Davies, A.R. (Andrew R.), Ponsford, J. (Jennie), Seppelt, I. (Ian), Reilly, P. (Peter), Wiegers, E. (Eveline), Wolfe, R. (R.), Cooper, D.J. (D. James), Rosenfeld, J.V. (Jeffrey V.), Murray, L. (Lynnette), Arabi, Y.M. (Yaseen M.), Davies, A.R. (Andrew R.), Ponsford, J. (Jennie), Seppelt, I. (Ian), Reilly, P. (Peter), Wiegers, E. (Eveline), and Wolfe, R. (R.)

Abstract

Functional outcomes at 12 months were a secondary outcome of the randomized DECRA trial of early decompressive craniectomy for severe diffuse traumatic brain injury (TBI) and refractory intracranial hypertension. In the DECRA trial, patients were randomly allocated 1:1 to either early decompressive craniectomy or intensive medical therapies (standard care). We conducted planned secondary analyses of the DECRA trial outcomes at 6 and 12 months, including all 155 patients. We measured functional outcome using the Glasgow Outcome Scale-Extended (GOS-E). We used ordered logistic regression, and dichotomized the GOS-E using logistic regression, to assess outcomes in patients overall and in survivors. We adjusted analyses for injury severity using the International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) model. At 12 months, the odds ratio (OR) for worse functional outcomes in the craniectomy group (OR 1.68; 95% confidence interval [CI]: 0.96-2.93; p = 0.07) was no longer significant. Unfavorable functional outcomes after craniectomy were 11% higher (59% compared with 48%), but were not significantly different from standard care (OR 1.58; 95% CI: 0.84-2.99; p = 0.16). Among survivors after craniectomy, there were fewer good (OR 0.33; 95% CI: 0.12-0.91; p = 0.03) and more vegetative (OR 5.12; 95% CI: 1.04-25.2; p = 0.04) outcomes. Similar outcomes in survivors were found at 6 months after injury. Vegetative (OR 5.85; 95% CI: 1.21-28.30; p = 0.03) and severely disabled outcomes (OR 2.49; 95% CI: 1.21-5.11; p = 0.01) were increased. Twelve months after severe diffuse TBI and early refractory intracranial hypertension, decompressive craniectomy did not improve outcomes and increased vegetative survivors.

Published
2020
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20. Early sedation with dexmedetomidine in critically ill patients.

Author

Seppelt I.M., Takala J., Wise M.P., Webb S.A., Shehabi Y., Howe B.D., Bellomo R., Arabi Y.M., Bailey M., Bass F.E., Bin Kadiman S., McArthur C.J., Murray L., Reade M.C., Seppelt I.M., Takala J., Wise M.P., Webb S.A., Shehabi Y., Howe B.D., Bellomo R., Arabi Y.M., Bailey M., Bass F.E., Bin Kadiman S., McArthur C.J., Murray L., and Reade M.C.

Abstract

BACKGROUND: Dexmedetomidine produces sedation while maintaining a degree of arousability and may reduce the duration of mechanical ventilation and delirium among patients in the intensive care unit (ICU). The use of dexmedetomidine as the sole or primary sedative agent in patients undergoing mechanical ventilation has not been extensively studied. METHOD(S): In an open-label, randomized trial, we enrolled critically ill adults who had been undergoing ventilation for less than 12 hours in the ICU and were expected to continue to receive ventilatory support for longer than the next calendar day to receive dexmedetomidine as the sole or primary sedative or to receive usual care (propofol, midazolam, or other sedatives). The target range of sedation-scores on the Richmond Agitation and Sedation Scale (which is scored from -5 [unresponsive] to +4 [combative]) was -2 to +1 (lightly sedated to restless). The primary outcome was the rate of death from any cause at 90 days. RESULT(S): We enrolled 4000 patients at a median interval of 4.6 hours between eligibility and randomization. In a modified intention-to-treat analysis involving 3904 patients, the primary outcome event occurred in 566 of 1948 (29.1%) in the dexmedetomidine group and in 569 of 1956 (29.1%) in the usual-care group (adjusted risk difference, 0.0 percentage points; 95% confidence interval, -2.9 to 2.8). An ancillary finding was that to achieve the prescribed level of sedation, patients in the dexmedetomidine group received supplemental propofol (64% of patients), midazolam (3%), or both (7%) during the first 2 days after randomization; in the usual-care group, these drugs were administered as primary sedatives in 60%, 12%, and 20% of the patients, respectively. Bradycardia and hypotension were more common in the dexmedetomidine group. CONCLUSION(S): Among patients undergoing mechanical ventilation in the ICU, those who received early dexmedetomidine for sedation had a rate of death at 90 days similar to that

Published
2019

22. Recovery after critical illness: putting the puzzle together-a consensus of 29

Author

Azoulay, E., Vincent, J.L., Angus, D.C., Arabi, Y.M., Brochard, L., Brett, S.J., Citerio, G., Cook, D.J., Curtis, J.R., Santos, C.C. Dos, Ely, E.W., Hall, J., Halpern, S.D., Hart, N. t, Hopkins, R.O., Iwashyna, T.J., Jaber, S., Latronico, N., Mehta, S., Needham, D.M., Nelson, J., Puntillo, K., Quintel, M., Rowan, K., Rubenfeld, G., Berghe, G. Van den, Hoeven, J.G. van der, Wunsch, H., Herridge, M., Azoulay, E., Vincent, J.L., Angus, D.C., Arabi, Y.M., Brochard, L., Brett, S.J., Citerio, G., Cook, D.J., Curtis, J.R., Santos, C.C. Dos, Ely, E.W., Hall, J., Halpern, S.D., Hart, N. t, Hopkins, R.O., Iwashyna, T.J., Jaber, S., Latronico, N., Mehta, S., Needham, D.M., Nelson, J., Puntillo, K., Quintel, M., Rowan, K., Rubenfeld, G., Berghe, G. Van den, Hoeven, J.G. van der, Wunsch, H., and Herridge, M.

Abstract

Contains fulltext : 182582.pdf (publisher's version ) (Open Access), In this review, we seek to highlight how critical illness and critical care affect longer-term outcomes, to underline the contribution of ICU delirium to cognitive dysfunction several months after ICU discharge, to give new insights into ICU acquired weakness, to emphasize the importance of value-based healthcare, and to delineate the elements of family-centered care. This consensus of 29 also provides a perspective and a research agenda about post-ICU recovery.

Published
2017

23. Time-limited trials of intensive care for critically Ill patients with cancer

Author

Shrime, M.G. (Mark G.), Ferket, B.S. (Bart), Scott, D.J. (Daniel J.), Lee, J. (Joon), Barragan-Bradford, D. (Diana), Pollard, T. (Tom), Arabi, Y.M. (Yaseen M.), Al-Dorzi, H.M. (Hasan M.), Baron, R.M. (Rebecca M.), Hunink, M.G.M. (Myriam), Celi, L.A. (Leo A.), Lai, P.S. (Peggy S.), Shrime, M.G. (Mark G.), Ferket, B.S. (Bart), Scott, D.J. (Daniel J.), Lee, J. (Joon), Barragan-Bradford, D. (Diana), Pollard, T. (Tom), Arabi, Y.M. (Yaseen M.), Al-Dorzi, H.M. (Hasan M.), Baron, R.M. (Rebecca M.), Hunink, M.G.M. (Myriam), Celi, L.A. (Leo A.), and Lai, P.S. (Peggy S.)

Abstract

__Importance__ Time-limited trials of intensive care are commonly used in patients perceived to have a poor prognosis. The optimal duration of such trials is unknown. Factors such as a cancer diagnosis are associated with clinician pessimism and may affect the decision to limit care independent of a patient’s severity of illness. __Objective__ To identify the optimal duration of intensive care for short-term mortality in critically ill patients with cancer. __Design, Setting, and Participants__ Decision analysis using a state-transition microsimulation model was performed to simulate the hospital course of patients with poor-prognosis primary tumors, metastatic disease, or hematologic malignant neoplasms admitted to medical and surgical intensive care units. Transition probabilities were derived from 920 participants stratified by sequential organ failure assessment (SOFA) scores to identify severity of illness. The model was validated in 3 independent cohorts with 349, 158, and 117 participants from quaternary care academic hospitals. Monte Carlo microsimulation was performed, followed by probabilistic sensitivity analysis. Outcomes were assessed in the overall cohort and in solid tumors alone. __Interventions__ Time-unlimited vs time-limited trials of intensive care. __Main Outcomes and Measures__ 30-day all-cause mortality and mean survival duration. __Results__ The SOFA scores at ICU admission were significantly associated with mortality. A 3-, 8-, or 15-day trial of intensive care resulted in decreased mean 30-day survival vs aggressive care in all but the sickest patients (SOFA score, 5-9: 48.4% [95% CI, 48.0%-48.8%], 60.6% [95% CI, 60.2%-61.1%], and 66.8% [95% CI, 66.4%-67.2%], respectively, vs 74.6% [95% CI, 74.3%-75.0%] with time-unlimited aggressive care; SOFA score, 10-14: 36.2% [95% CI, 35.8%-36.6%], 44.1% [95% CI, 43.6%-44.5%], and 46.1% [95% CI, 45.6%-46.5%], respectively, vs 48.4% [95% CI, 48.0%-48.8%] with aggressive care; SOFA score, ≥15: 5.8% [95%

Published
2016
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25. Microbiology of Community-Acquired Pneumonia in the Gulf Corporation Council States

Author

Memish, Z.A., Ahmed, Q.A., Arabi, Y.M., Shibl, A.M., and Niederman, M.S.

Abstract

SummaryIn spite of advances in microbiological and serological investigations over the last two decades, etiological attribution remains difficult in community-acquired pneumonia (CAP). Even after exhaustive investigation, the etiology of CAP remains unknown in up to 50% of patients. Common pathogens include Streptococcus pneumoniae, Haemophilus influenzaeand Moraxella catarrhalis. In addition, several investigators document the importance of atypical pathogens including Mycoplasma pneumoniae, Chlamydophila pneumoniaeand Legionella pneumophilain the etiology of CAP in the GCC region. Increasingly, other etiologies, particularly influenza viruses, varicella zoster virus and Mycobacterium tuberculosis, have been recognized as causative pathogens of CAP within the region. Rates of antimicrobial resistance of S. pneumoniaeand other pathogens are rising in the Gulf Corporation Council (GCC) region and susceptibility profiles of antibiotics against intracellular pathogens such as Chlamydophila pneumoniaeand Mycoplasma pneumoniaeare not routinely performed. Injudicious prescribing and over-use of antibiotics drive much resistance. The GCC CAPWG calls for urgent governmental regulations to limit and monitor antibiotic prescription in the GCC region.

Published
2007
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26. Management and Prevention Strategies for Community-Acquired Pneumonia in the Gulf Corporation Council

Author

Memish, Z.A., Arabi, Y.M., Ahmed, Q.A., Shibl, A.M., and Niederman, M.S.

Abstract

SummaryRisk factors identify likelihood and severity of community-acquired pneumonia (CAP) and may allow prognostication. Prognostic factors can focus resources and efforts on those who may need special observation. Several risk assessment tools are used to estimate the severity of CAP and whether these tools can be used to predict outcomes, to determine disposition or even used to determine ICU level of care is hotly under debate. Treating CAP depends on age and comorbidities, as well as local epidemiology and disease severity. The current guidelines for managing CAP categorize patients with CAP into the healthy outpatient, the outpatient with modifying factors or comorbidities, the inpatient with CAP and patients requiring intensive care unit admission. These guidelines took into account regional bacteriology, antibiotic resistance data and available antibiotics to formulate recommendations. Preventive strategies for CAP include the administration of pneumococcal and influenza vaccine in selected populations at risk.

Published
2007
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27. Clinical Presentation and Diagnostic Workup for Community-Acquired Pneumonia: The Gulf Corporation Council CAP Working Group Consensus Statement

Author

Memish, Z.A., Arabi, Y.M., Ahmed, Q.A., Al Jahdali, H., Shibl, A.M., and Niederman, M.S.

Abstract

SummaryCommunity-acquired pneumonia (CAP) is diagnosed on the basis of a suggestive history and compatible physical findings and new infiltrates on a chest radiograph. No criteria or combination of criteria based on history and physical examination have been found to be gold standard. With the rise in elderly Gulf Cooperation Council (GCC) residents, CAP is likely to present with non-classical manifestations such as somnolence, new anorexia, and confusion and carries a worse outcome than CAP in their younger counterparts. Tuberculosis should be considered in the differential diagnosis of unresolving CAP in the GCC region. Diagnostic work up depends on severity of CAP, clinical course and underlying risk factors.

Published
2007
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29. Resolved versus confirmed ARDS after 24 h: insights from the LUNG SAFE study

Author

Madotto, F., Pham, T., Bellani, G., Bos, L. D., Simonis, F. D., Fan, E., Artigas, A., Brochard, L., Schultz, M. J., Laffey, J. G., Pesenti, A., Esteban, A., Gattinoni, L., van Haren, F., Larsson, A., McAuley, D. F., Ranieri, M., Rubenfeld, G., Thompson, B. T., Wrigge, H., Slutsky, A. S., Rios, F., Van Haren, F., Sottiaux, T., Depuydt, P., Lora, F. S., Azevedo, L. C., Bugedo, G., Qiu, H., Gonzalez, M., Silesky, J., Cerny, V., Nielsen, J., Jibaja, M., Matamis, D., Ranero, J. L., Amin, P., Hashemian, S. M., Clarkson, K., Kurahashi, K., Villagomez, A., Zeggwagh, A. A., Heunks, L. M., Laake, J. H., Palo, J. E., do Vale Fernandes, A., Sandesc, D., Arabi, Y., Bumbasierevic, V., Nin, N., Lorente, J. A., Piquilloud, L., Abroug, F., McNamee, L., Hurtado, J., Bajwa, E., Démpaire, G., Sula, H., Nunci, L., Cani, A., Zazu, A., Dellera, C., Alejandro, R. V., Daldin, J., Vinzio, M., Fernandez, R. O., Cardonnet, L. P., Bettini, L. R., Bisso, M. C., Osman, E. M., Setten, M. G., Lovazzano, P., Alvarez, J., Villar, V., Pozo, N. C., Grubissich, N., Plotnikow, G. A., Vasquez, D. N., Ilutovich, S., Tiribelli, N., Chena, A., Pellegrini, C. A., Saenz, M. G., Estenssoro, E., Brizuela, M., Gianinetto, H., Gomez, P. E., Cerrato, V. I., Bezzi, M. G., Borello, S. A., Loiacono, F. A., Fernandez, A. M., Knowles, S., Reynolds, C., Inskip, D. M., Miller, J. J., Kong, J., Whitehead, C., Bihari, S., Seven, A., Krstevski, A., Rodgers, H. J., Millar, R. T., Mckenna, T. E., Bailey, I. M., Hanlon, G. C., Aneman, A., Lynch, J. M., Azad, R., Neal, J., Woods, P. W., Roberts, B. L., Kol, M. R., Wong, H. S., Riss, K. C., Staudinger, T., Wittebole, X., Berghe, C., Bulpa, P. A., Dive, A. M., Verstraete, R., Lebbinck, H., Vermassen, J., Meersseman, P., Ceunen, H., Rosa, J. I., Beraldo, D. O., Piras, C., Rampinelli, A. M., Nassar A. P., Jr., Mataloun, S., Moock, M., Thompson, M. M., Gonçalves, C. H., Antônio, A. C. P., Ascoli, A., Biondi, R. S., Fontenele, D. C., Nobrega, D., Sales, V. M., Shindhe, S., Ismail, D. M. A. B. P. H., Laffey, J., Beloncle, F., Davies, K. G., Cirone, R., Manoharan, V., Ismail, M., Goligher, E. C., Jassal, M., Nishikawa, E., Javeed, A., Curley, G., Rittayamai, N., Parotto, M., Ferguson, N. D., Mehta, S., Knoll, J., Pronovost, A., Canestrini, S., Bruhn, A. R., Garcia, P. H., Aliaga, F. A., Farías, P. A., Yumha, J. S., Ortiz, C. A., Salas, J. E., Saez, A. A., Vega, L. D., Labarca, E. F., Martinez, F. T., Carreño, N. G., Lora, P., Liu, H., Liu, L., Tang, R., Luo, X., An, Y., Zhao, H., Gao, Y., Zhai, Z., Ye, Z. L., Wang, W., Li, W., Li, Q., Zheng, R., Yu, W., Shen, J., Li, X., Yu, T., Lu, W., Wu, Y. Q., Huang, X. B., He, Z., Lu, Y., Han, H., Zhang, F., Sun, R., Wang, H. X., Qin, S. H., Zhu, B. H., Zhao, J., Liu, J., Li, B., Liu, J. L., Zhou, F. C., Li, Q. J., Zhang, X. Y., Li-Xin, Z., Xin-Hua, Q., Jiang, L., Gao, Y. N., Zhao, X. Y., Li, Y. Y., Li, X. L., Wang, C., Yao, Q., Yu, R., Chen, K., Shao, H., Qin, B., Huang, Q. Q., Zhu, W. H., Hang, A. Y., Hua, M. X., Li, Y., Xu, Y., Di, Y. D., Ling, L. L., Qin, T. H., Wang, S. H., Qin, J., Han, Y., Zhou, S., Vargas, M. P., Jimenez, J. I. S., Rojas, M. A. G., Solis-Quesada, J. E., Ramirez-Alfaro, C. M., Máca, J., Sklienka, P., Gjedsted, J., Christiansen, A., Villamagua, B. G., Llano, M., Burtin, P., Buzancais, G., Beuret, P., Pelletier, N., Mortaza, S., Mercat, A., Chelly, J., Jochmans, S., Terzi, N., Daubin, C., Carteaux, G., de Prost, N., Chiche, J. -D., Daviaud, F., Fartoukh, M., Barberet, G., Biehler, J., Dellamonica, J., Doyen, D., Arnal, J. -M., Briquet, A., Hraiech, S., Papazian, L., Roux, D., Messika, J., Kalaitzis, E., Dangers, L., Combes, A., Au, S. -M., Béduneau, G., Carpentier, D., Zogheib, E. H., Dupont, H., Ricome, S., Santoli, F. L., Besset, S. L., Michel, P., Gelée, B., Danin, P. -E., Goubaux, B., Crova, P. J., Phan, N. T., Berkelmans, F., Badie, J. C., Tapponnier, R., Gally, J., Khebbeb, S., Herbrecht, J. -E., Schneider, F., Declercq, P. -L. M., Rigaud, J. -P., Duranteau, J., Harrois, A., Chabanne, R., Marin, J., Bigot, C., Thibault, S., Ghazi, M., Boukhazna, M., Zein, S. O., Richecoeur, J. R., Combaux, D. M., Grelon, F., Le Moal, C., Sauvadet, E. P., Robine, A., Lemiale, V., Reuter, D., Dres, M., Demoule, A., Goldgran-Toledano, D., Baboi, L., Guérin, C., Lohner, R., Kraßler, J., Schäfer, S., Zacharowski, K. D., Meybohm, P., Reske, A. W., Simon, P., Hopf, H. -B. F., Schuetz, M., Baltus, T., Papanikolaou, M. N., Papavasilopoulou, T. G., Zacharas, G. A., Ourailogloy, V., Mouloudi, E. K., Massa, E. V., Nagy, E. O., Stamou, E. E., Kiourtzieva, E. V., Oikonomou, M. A., Avila, L. E., Cortez, C. A., Citalán, J. E., Jog, S. A., Sable, S. D., Shah, B., Gurjar, M., Baronia, A. K., Memon, M., Muthuchellappan, R., Ramesh, V. J., Shenoy, A., Unnikrishnan, R., Dixit, S. B., Rhayakar, R. V., Ramakrishnan, N., Bhardwaj, V. K., Mahto, H. L., Sagar, S. V., Palaniswamy, V., Ganesan, D., Jamaati, H., Heidari, F., Meaney, E. A., Nichol, A., Knapman, K. M., O’Croinin, D., Dunne, E. S., Breen, D. M., Clarkson, K. P., Jaafar, R. F., Dwyer, R., Amir, F., Ajetunmobi, O. O., O’Muircheartaigh, A. C., Black, C. S., Treanor, N., Collins, D. V., Altaf, W., Zani, G., Fusari, M., Spadaro, S., Volta, C. A., Graziani, R., Brunettini, B., Palmese, S., Formenti, P., Umbrello, M., Lombardo, A., Pecci, E., Botteri, M., Savioli, M., Protti, A., Mattei, A., Schiavoni, L., Tinnirello, A., Todeschini, M., Giarratano, A., Cortegiani, A., Sher, S., Rossi, A., Antonelli, M. M., Montini, L. M., Casalena, P., Scafetti, S., Panarello, G., Occhipinti, G., Patroniti, N., Pozzi, M., Biscione, R. R., Poli, M. M., Raimondi, F., Albiero, D., Crapelli, G., Beck, E., Pota, V., Schiavone, V., Molin, A., Tarantino, F., Monti, G., Frati, E., Mirabella, L., Cinnella, G., Fossali, T., Colombo, R., Pattarino, P. T. I., Mojoli, F., Braschi, A., Borotto, E. E., Cracchiolo, A. N., Palma, D. M., Raponi, F., Foti, G., Vascotto, E. R., Coppadoro, A., Brazzi, L., Floris, L., Iotti, G. A., Venti, A., Yamaguchi, O., Takagi, S., Maeyama, H. N., Watanabe, E., Yamaji, Y., Shimizu, K., Shiozaki, K., Futami, S., Ryosuke, S., Saito, K., Kameyama, Y., Ueno, K., Izawa, M., Okuda, N., Suzuki, H., Harasawa, T., Nasu, M., Takada, T., Ito, F., Nunomiya, S., Koyama, K., Abe, T., Andoh, K., Kusumoto, K., Hirata, A., Takaba, A., Kimura, H., Matsumoto, S., Higashijima, U., Honda, H., Aoki, N., Imai, H., Ogino, Y., Mizuguchi, I., Ichikado, K., Nitta, K., Mochizuki, K., Hashida, T., Tanaka, H., Nakamura, T., Niimi, D., Ueda, T., Kashiwa, Y., Uchiyama, A., Sabelnikovs, O., Oss, P., Haddad, Y., Liew, K. Y., Ñamendys-Silva, S. A., Jarquin-Badiola, Y. D., Sanchez-Hurtado, L. A., Gomez-Flores, S. S., Marin, M. C., Villagomez, A. J., Lemus, J. S., Fierro, J. M., Cervantes, M. R., Mejia, F. J. F., Dector, D., Dector, D. M., Gonzalez, D. R., Estrella, C. R., Sanchez-Medina, J. R., Ramirez-Gutierrez, A., George, F. G., Aguirre, J. S., Buensuseso, J. A., Poblano, M., Dendane, T., Balkhi, H., Elkhayari, M., Samkaoui, N., Ezzouine, H., Benslama, A., Amor, M., Maazouzi, W., Cimic, N., Beck, O., Bruns, M. M., Schouten, J. A., Rinia, M., Raaijmakers, M., Van Wezel, H. M., Heines, S. J., Strauch, U., Buise, M. P., Goodson, J. C., Browne, T. S., Navarra, L., Hunt, A., Hutchison, R. A., Bailey, M. B., Newby, L., Mcarthur, C., Kalkoff, M., Mcleod, A., Casement, J., Hacking, D. J., Andersen, F. H., Dolva, M. S., Barratt-Due, A., Noremark, K. A. L., Søreide, E., Sjøbø, B. Å., Guttormsen, A. B., Yoshido, H. H. L., Aguilar, R. Z., Oscanoa, F. A. M., Alisasis, A. U., Robles, J. B., Pasanting-Lim, R. A. B., Tan, B. C., Andruszkiewicz, P., Jakubowska, K., Coxo, C. M., Alvarez, A. M., Oliveira, B. S., Montanha, G. M., Barros, N. C., Pereira, C. S., Messias, A. M., Monteiro, J. M., Araujo, A. M., Catorze, N. T., Marum, S. M., Bouw, M. J., Gomes, R. M., Brito, V. A., Castro, S., Estilita, J. M., Barros, F. M., Serra, I. M., Martinho, A. M., Tomescu, D. R., Marcu, A., Bedreag, O. H., Papurica, M., Corneci, D. E., Negoita, S. L., Grigoriev, E., Gritsan, A. I., Gazenkampf, A. A., Almekhlafi, G., Albarrak, M. M., Mustafa, G. M., Maghrabi, K. A., Salahuddin, N., Aisa, T. M., Jabbary, A. S. A., Tabhan, E., Arabi, Y. M., Trinidad, O. A., Dorzi, H. M. A., Tabhan, E. E., Bolon, S., Smith, O., Mancebo, J., Aguirre-Bermeo, H., Lopez-Delgado, J. C., Esteve, F., Rialp, G., Forteza, C., De Haro, C., Albaiceta, G. M., De Cima-Iglesias, S., Seoane-Quiroga, L., Ceniceros-Barros, A., Ruiz-Aguilar, A. L., Claraco-Vega, L. M., Soler, J. A., del Carmen Lorente, M., Hermosa, C., Gordo, F., Prieto-González, M., López-Messa, J. B., Perez, M. P., Perez, C. P., Allue, R. M., Roche-Campo, F., Ibañez-Santacruz, M., Temprano, S., Pintado, M. C., De Pablo, R., Gómez, P. R. A., Ruiz, S. R., Moles, S. I., Jurado, M. ªT., Arizmendi, A., Piacentini, E. A., Franco, N., Honrubia, T., Cheng, M. P., Losada, E. P., Blanco, J., Yuste, L. J., Carbayo-Gorriz, C., Cazorla-Barranquero, F. G., Alonso, J. G., Alda, R. S., Algaba, Á., Navarro, G., Cereijo, E., Diaz-Rodriguez, E., Marcos, D. P., Montero, L. A., Para, L. H., Sanchez, R. J., Navalpotro, M. A. B., Abad, R. D., González, R. M., Toribio, D. P., Castro, A. G., Artiga, M. J. D., Penuelas, O., Roser, T. P., Olga, M. F., Curto, E. G., Sánchez, R. M., Imma, V. P., Elisabet, G. M., Claverias, L., Magret, M., Pellicer, A. M., Rodriguez, L. L., Sánchez-Ballesteros, J., González-Salamanca, Á., Jimenez, A. G., Huerta, F. P., Diaz, J. C. J. S., Lopez, E. B., Moya, D. D. L., Alfonso, A. A. T., Luis, P. S. E., Cesar, P. S., Rafael, S. I., Virgilio, C. G., Recio, N. N., Adamsson, R. O., Rylander, C. C., Holzgraefe, B., Broman, L. M., Wessbergh, J., Persson, L., Schiöler, F., Kedelv, H., Tibblin, A. O., Appelberg, H., Hedlund, L., Helleberg, J., Eriksson, K. 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L., Ioannou, N., Gillis, S., Csabi, P., Macfadyen, R., Dawson, H., Preez, P. D., Williams, A. J., Boyd, O., De Gordoa, L. O. -R., Bramall, J., Symmonds, S., Chau, S. K., Wenham, T., Szakmany, T., Toth-Tarsoly, P., McCalman, K. H., Alexander, P., Stephenson, L., Collyer, T., Chapman, R., Cooper, R., Allan, R. M., Sim, M., Wrathall, D. W., Irvine, D. A., Zantua, K. S., Adams, J. C., Burtenshaw, A. J., Sellors, G. P., Welters, I. D., Williams, K. E., Hessell, R. J., Oldroyd, M. G., Battle, C. E., Pillai, S., Kajtor, I., Sivashanmugavel, M., O’Kane, S. C., Donnelly, A., Frigyik, A. D., Careless, J. P., May, M. M., Stewart, R., Trinder, T. J., Hagan, S. J., Wise, M. P., Cole, J. M., MacFie, C. C., Dowling, A. T., Nuñez, E., Pittini, G., Rodriguez, R., Imperio, M. C., Santos, C., França, A. G., Ebeid, A., Deicas, A., Serra, C., Uppalapati, A., Kamel, G., Banner-Goodspeed, V. M., Beitler, J. R., Mukkera, S. R., Kulkarni, S., Lee, J., Mesar, T., Shinn, J. 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L., Schomer, A., Bumbasirevic, V., Jovanovic, B., Surbatovic, M., Veljovic, M., LUNG SAFE Investigators and the ESICM Trials Group, Madotto, F., Pham, T., Bellani, G., Bos, L.D., Simonis, F.D., Fan, E., Artigas, A., Brochard, L., Schultz, M.J., Laffey, J.G., Pesenti, A., Esteban, A., Gattinoni, L., van Haren, F., Larsson, A., McAuley, D.F., Ranieri, M., Rubenfeld, G., Thompson, B.T., Wrigge, H., Slutsky, A.S., Rios, F., Van Haren, F., Sottiaux, T., Depuydt, P., Lora, F.S., Azevedo, L.C., Bugedo, G., Qiu, H., Gonzalez, M., Silesky, J., Cerny, V., Nielsen, J., Jibaja, M., Matamis, D., Ranero, J.L., Amin, P., Hashemian, S.M., Clarkson, K., Kurahashi, K., Villagomez, A., Zeggwagh, A.A., Heunks, L.M., Laake, J.H., Palo, J.E., do Vale Fernandes, A., Sandesc, D., Arabi, Y., Bumbasierevic, V., Nin, N., Lorente, J.A., Piquilloud, L., Abroug, F., McNamee, L., Hurtado, J., Bajwa, E., Démpaire, G., Sula, H., Nunci, L., Cani, A., Zazu, A., Dellera, C., Alejandro, R.V., Daldin, J., Vinzio, M., 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Schomer, A., Bumbasirevic, V., Jovanovic, B., Surbatovic, M., Veljovic, M., LUNG SAFE Investigators and the ESICM Trials Group, Madotto, F, Pham, T, Bellani, G, Bos, L, Simonis, F, Fan, E, Artigas, A, Brochard, L, Schultz, M, Laffey, J, Pesenti, A, Esteban, A, Gattinoni, L, van Haren, F, Larsson, A, Mcauley, D, Ranieri, M, Rubenfeld, G, Thompson, B, Wrigge, H, Slutsky, A, Rios, F, Sottiaux, T, Depuydt, P, Lora, F, Azevedo, L, Bugedo, G, Qiu, H, Gonzalez, M, Silesky, J, Cerny, V, Nielsen, J, Jibaja, M, Matamis, D, Ranero, J, Amin, P, Hashemian, S, Clarkson, K, Kurahashi, K, Villagomez, A, Zeggwagh, A, Heunks, L, Laake, J, Palo, J, Do Vale Fernandes, A, Sandesc, D, Arabi, Y, Bumbasierevic, V, Nin, N, Lorente, J, Piquilloud, L, Abroug, F, Mcnamee, L, Hurtado, J, Bajwa, E, Démpaire, G, Sula, H, Nunci, L, Cani, A, Zazu, A, Dellera, C, Alejandro, R, Daldin, J, Vinzio, M, Fernandez, R, Cardonnet, L, Bettini, L, Bisso, M, Osman, E, Setten, M, Lovazzano, P, Alvarez, J, Villar, V, Pozo, N, Grubissich, N, Plotnikow, G, Vasquez, D, Ilutovich, S, Tiribelli, N, Chena, A, Pellegrini, C, Saenz, M, Estenssoro, E, Brizuela, M, Gianinetto, H, Gomez, P, Cerrato, V, Bezzi, M, Borello, S, Loiacono, F, Fernandez, A, Knowles, S, Reynolds, C, Inskip, D, Miller, J, Kong, J, Whitehead, C, Bihari, S, Seven, A, Krstevski, A, Rodgers, H, Millar, R, Mckenna, T, Bailey, I, Hanlon, G, Aneman, A, Lynch, J, Azad, R, Neal, J, Woods, P, Roberts, B, Kol, M, Wong, H, Riss, K, Staudinger, T, Wittebole, X, Berghe, C, Bulpa, P, Dive, A, Verstraete, R, Lebbinck, H, Vermassen, J, Meersseman, P, Ceunen, H, Rosa, J, Beraldo, D, Piras, C, Rampinelli, A, Nassar, A, Mataloun, S, Moock, M, Thompson, M, Gonçalves, C, Antônio, A, Ascoli, A, Biondi, R, Fontenele, D, Nobrega, D, Sales, V, Shindhe, S, Ismail, D, Beloncle, F, Davies, K, Cirone, R, Manoharan, V, Ismail, M, Goligher, E, Jassal, M, Nishikawa, E, Javeed, A, Curley, G, Rittayamai, N, Parotto, M, Ferguson, N, Mehta, S, Knoll, J, Pronovost, A, Canestrini, S, Bruhn, A, Garcia, P, Aliaga, F, Farías, P, Yumha, J, Ortiz, C, Salas, J, Saez, A, Vega, L, Labarca, E, Martinez, F, Carreño, N, Lora, P, Liu, H, Liu, L, Tang, R, Luo, X, An, Y, Zhao, H, Gao, Y, Zhai, Z, Ye, Z, Wang, W, Li, W, Li, Q, Zheng, R, Yu, W, Shen, J, Li, X, Yu, T, Lu, W, Wu, Y, Huang, X, He, Z, Lu, Y, Han, H, Zhang, F, Sun, R, Wang, H, Qin, S, Zhu, B, Zhao, J, Liu, J, Li, B, Zhou, F, Zhang, X, Li-Xin, Z, Xin-Hua, Q, Jiang, L, Zhao, X, Li, Y, Wang, C, Yao, Q, Yu, R, Chen, K, Shao, H, Qin, B, Huang, Q, Zhu, W, Hang, A, Hua, M, Xu, Y, Di, Y, Ling, L, Qin, T, Wang, S, Qin, J, Han, Y, Zhou, S, Vargas, M, Jimenez, J, Rojas, M, Solis-Quesada, J, Ramirez-Alfaro, C, Máca, J, Sklienka, P, Gjedsted, J, Christiansen, A, Villamagua, B, Llano, M, Burtin, P, Buzancais, G, Beuret, P, Pelletier, N, Mortaza, S, Mercat, A, Chelly, J, Jochmans, S, Terzi, N, Daubin, C, Carteaux, G, de Prost, N, Chiche, J, Daviaud, F, Fartoukh, M, Barberet, G, Biehler, J, Dellamonica, J, Doyen, D, Arnal, J, Briquet, A, Hraiech, S, Papazian, L, Roux, D, Messika, J, Kalaitzis, E, Dangers, L, Combes, A, Au, S, Béduneau, G, Carpentier, D, Zogheib, E, Dupont, H, Ricome, S, Santoli, F, Besset, S, Michel, P, Gelée, B, Danin, P, Goubaux, B, Crova, P, Phan, N, Berkelmans, F, Badie, J, Tapponnier, R, Gally, J, Khebbeb, S, Herbrecht, J, Schneider, F, Declercq, P, Rigaud, J, Duranteau, J, Harrois, A, Chabanne, R, Marin, J, Bigot, C, Thibault, S, Ghazi, M, Boukhazna, M, Zein, S, Richecoeur, J, Combaux, D, Grelon, F, Le Moal, C, Sauvadet, E, Robine, A, Lemiale, V, Reuter, D, Dres, M, Demoule, A, Goldgran-Toledano, D, Baboi, L, Guérin, C, Lohner, R, Kraßler, J, Schäfer, S, Zacharowski, K, Meybohm, P, Reske, A, Simon, P, Hopf, H, Schuetz, M, Baltus, T, Papanikolaou, M, Papavasilopoulou, T, Zacharas, G, Ourailogloy, V, Mouloudi, E, Massa, E, Nagy, E, Stamou, E, Kiourtzieva, E, Oikonomou, M, Avila, L, Cortez, C, Citalán, J, Jog, S, Sable, S, Shah, B, Gurjar, M, Baronia, A, Memon, M, Muthuchellappan, R, Ramesh, V, Shenoy, A, Unnikrishnan, R, Dixit, S, Rhayakar, R, Ramakrishnan, N, Bhardwaj, V, Mahto, H, Sagar, S, Palaniswamy, V, Ganesan, D, Jamaati, H, Heidari, F, Meaney, E, Nichol, A, Knapman, K, O’Croinin, D, Dunne, E, Breen, D, Jaafar, R, Dwyer, R, Amir, F, Ajetunmobi, O, O’Muircheartaigh, A, Black, C, Treanor, N, Collins, D, Altaf, W, Zani, G, Fusari, M, Spadaro, S, Volta, C, Graziani, R, Brunettini, B, Palmese, S, Formenti, P, Umbrello, M, Lombardo, A, Pecci, E, Botteri, M, Savioli, M, Protti, A, Mattei, A, Schiavoni, L, Tinnirello, A, Todeschini, M, Giarratano, A, Cortegiani, A, Sher, S, Rossi, A, Antonelli, M, Montini, L, Casalena, P, Scafetti, S, Panarello, G, Occhipinti, G, Patroniti, N, Pozzi, M, Biscione, R, Poli, M, Raimondi, F, Albiero, D, Crapelli, G, Beck, E, Pota, V, Schiavone, V, Molin, A, Tarantino, F, Monti, G, Frati, E, Mirabella, L, Cinnella, G, Fossali, T, Colombo, R, Pattarino, P, Mojoli, F, Braschi, A, Borotto, E, Cracchiolo, A, Palma, D, Raponi, F, Foti, G, Vascotto, E, Coppadoro, A, Brazzi, L, Floris, L, Iotti, G, Venti, A, Yamaguchi, O, Takagi, S, Maeyama, H, Watanabe, E, Yamaji, Y, Shimizu, K, Shiozaki, K, Futami, S, Ryosuke, S, Saito, K, Kameyama, Y, Ueno, K, Izawa, M, Okuda, N, Suzuki, H, Harasawa, T, Nasu, M, Takada, T, Ito, F, Nunomiya, S, Koyama, K, Abe, T, Andoh, K, Kusumoto, K, Hirata, A, Takaba, A, Kimura, H, Matsumoto, S, Higashijima, U, Honda, H, Aoki, N, Imai, H, Ogino, Y, Mizuguchi, I, Ichikado, K, Nitta, K, Mochizuki, K, Hashida, T, Tanaka, H, Nakamura, T, Niimi, D, Ueda, T, Kashiwa, Y, Uchiyama, A, Sabelnikovs, O, Oss, P, Haddad, Y, Liew, K, Ñamendys-Silva, S, Jarquin-Badiola, Y, Sanchez-Hurtado, L, Gomez-Flores, S, Marin, M, Lemus, J, Fierro, J, Cervantes, M, Mejia, F, Dector, D, Gonzalez, D, Estrella, C, Sanchez-Medina, J, Ramirez-Gutierrez, A, George, F, Aguirre, J, Buensuseso, J, Poblano, M, Dendane, T, Balkhi, H, Elkhayari, M, Samkaoui, N, Ezzouine, H, Benslama, A, Amor, M, Maazouzi, W, Cimic, N, Beck, O, Bruns, M, Schouten, J, Rinia, M, Raaijmakers, M, van Wezel, H, Heines, S, Strauch, U, Buise, M, Goodson, J, Browne, T, Navarra, L, Hunt, A, Hutchison, R, Bailey, M, Newby, L, Mcarthur, C, Kalkoff, M, Mcleod, A, Casement, J, Hacking, D, Andersen, F, Dolva, M, Barratt-Due, A, Noremark, K, Søreide, E, Sjøbø, B, Guttormsen, A, Yoshido, H, Aguilar, R, Oscanoa, F, Alisasis, A, Robles, J, Pasanting-Lim, R, Tan, B, Andruszkiewicz, P, Jakubowska, K, Coxo, C, Alvarez, A, Oliveira, B, Montanha, G, Barros, N, Pereira, C, Messias, A, Monteiro, J, Araujo, A, Catorze, N, Marum, S, Bouw, M, Gomes, R, Brito, V, Castro, S, Estilita, J, Barros, F, Serra, I, Martinho, A, Tomescu, D, Marcu, A, Bedreag, O, Papurica, M, Corneci, D, Negoita, S, Grigoriev, E, Gritsan, A, Gazenkampf, A, Almekhlafi, G, Albarrak, M, Mustafa, G, Maghrabi, K, Salahuddin, N, Aisa, T, Jabbary, A, Tabhan, E, Trinidad, O, Dorzi, H, Bolon, S, Smith, O, Mancebo, J, Aguirre-Bermeo, H, Lopez-Delgado, J, Esteve, F, Rialp, G, Forteza, C, de Haro, C, Albaiceta, G, de Cima-Iglesias, S, Seoane-Quiroga, L, Ceniceros-Barros, A, Ruiz-Aguilar, A, Claraco-Vega, L, Soler, J, Del Carmen Lorente, M, Hermosa, C, Gordo, F, Prieto-González, M, López-Messa, J, Perez, M, Perez, C, Allue, R, Roche-Campo, F, Ibañez-Santacruz, M, Temprano, S, Pintado, M, de Pablo, R, Gómez, P, Ruiz, S, Moles, S, Jurado, M, Arizmendi, A, Piacentini, E, Franco, N, Honrubia, T, Cheng, M, Losada, E, Blanco, J, Yuste, L, Carbayo-Gorriz, C, Cazorla-Barranquero, F, Alonso, J, Alda, R, Algaba, Á, Navarro, G, Cereijo, E, Diaz-Rodriguez, E, Marcos, D, Montero, L, Para, L, Sanchez, R, Navalpotro, M, Abad, R, González, R, Toribio, D, Castro, A, Artiga, M, Penuelas, O, Roser, T, Olga, M, Curto, E, Sánchez, R, Imma, V, Elisabet, G, Claverias, L, Magret, M, Pellicer, A, Rodriguez, L, Sánchez-Ballesteros, J, González-Salamanca, Á, Jimenez, A, Huerta, F, Diaz, J, Lopez, E, Moya, D, Alfonso, A, Luis, P, Cesar, P, Rafael, S, Virgilio, C, Recio, N, Adamsson, R, Rylander, C, Holzgraefe, B, Broman, L, Wessbergh, J, Persson, L, Schiöler, F, Kedelv, H, Tibblin, A, Appelberg, H, Hedlund, L, Helleberg, J, Eriksson, K, Glietsch, R, Larsson, N, Nygren, I, Nunes, S, Morin, A, Kander, T, Adolfsson, A, Zender, H, Leemann-Refondini, C, Elatrous, S, Bouchoucha, S, Chouchene, I, Ouanes, I, Souissi, A, Kamoun, S, Demirkiran, O, Aker, M, Erbabacan, E, Ceylan, I, Girgin, N, Ozcelik, M, Ünal, N, Meco, B, Akyol, O, Derman, S, Kennedy, B, Parhar, K, Srinivasa, L, Hopkins, P, Mellis, C, Kakar, V, Hadfield, D, Vercueil, A, Bhowmick, K, Humphreys, S, Ferguson, A, Mckee, R, Raj, A, Fawkes, D, Watt, P, Twohey, L, Thomas, R, Morton, A, Kadaba, V, Smith, M, Hormis, A, Kannan, S, Namih, M, Reschreiter, H, Camsooksai, J, Kumar, A, Rugonfalvi, S, Nutt, C, O’Neill, O, Seasman, C, Dempsey, G, Scott, C, Ellis, H, Mckechnie, S, Hutton, P, Di Tomasso, N, Vitale, M, Griffin, R, Dean, M, Cranshaw, J, Willett, E, Ioannou, N, Gillis, S, Csabi, P, Macfadyen, R, Dawson, H, Preez, P, Williams, A, Boyd, O, de Gordoa, L, Bramall, J, Symmonds, S, Chau, S, Wenham, T, Szakmany, T, Toth-Tarsoly, P, Mccalman, K, Alexander, P, Stephenson, L, Collyer, T, Chapman, R, Cooper, R, Allan, R, Sim, M, Wrathall, D, Irvine, D, Zantua, K, Adams, J, Burtenshaw, A, Sellors, G, Welters, I, Williams, K, Hessell, R, Oldroyd, M, Battle, C, Pillai, S, Kajtor, I, Sivashanmugavel, M, O’Kane, S, Donnelly, A, Frigyik, A, Careless, J, May, M, Stewart, R, Trinder, T, Hagan, S, Wise, M, Cole, J, Macfie, C, Dowling, A, Nuñez, E, Pittini, G, Rodriguez, R, Imperio, M, Santos, C, França, A, Ebeid, A, Deicas, A, Serra, C, Uppalapati, A, Kamel, G, Banner-Goodspeed, V, Beitler, J, Mukkera, S, Kulkarni, S, Lee, J, Mesar, T, Shinn, J, Gomaa, D, Tainter, C, Yeatts, D, Warren, J, Lanspa, M, Miller, R, Grissom, C, Brown, S, Bauer, P, Gosselin, R, Kitch, B, Cohen, J, Beegle, S, Gueret, R, Tulaimat, A, Choudry, S, Stigler, W, Batra, H, Huff, N, Lamb, K, Oetting, T, Mohr, N, Judy, C, Saito, S, Kheir, F, Schlichting, A, Delsing, A, Crouch, D, Elmasri, M, Dreyer, K, Blakeman, T, Baron, R, Grijalba, C, Hou, P, Seethala, R, Aisiku, I, Henderson, G, Frendl, G, Hou, S, Owens, R, Schomer, A, Bumbasirevic, V, Jovanovic, B, Surbatovic, M, Veljovic, M, Madotto, Fabiana, Pham, Tài, Bellani, Giacomo, Bos, Lieuwe D., Simonis, Fabienne D., Fan, Eddy, Artigas, Antonio, Brochard, Laurent, Schultz, Marcus J., Laffey, John G., Pesenti, Antonio, Esteban, Andre, Gattinoni, Luciano, van Haren, Frank, Larsson, Ander, McAuley, Daniel F., Ranieri, Marco, Rubenfeld, Gordon, Thompson, B. Taylor, Wrigge, Hermann, Slutsky, Arthur S., Rios, Fernando, Lora, Fredy S., Azevedo, Luciano Cesar, Bugedo, Guillermo, Qiu, Haibo, Gonzalez, Marco, Silesky, Juan, Cerny, Vladimir, Nielsen, Jona, Jibaja, Manuel, Matamis, Dimitrio, Ranero, Jorge Lui, Amin, Pravin, Clarkson, Kevin, Kurahashi, Kiyoyasu, Villagomez, Asisclo, Zeggwagh, Amine Ali, Heunks, Leo M., Laake, Jon Henrik, Palo, Jose Emmanuel, Do Vale Fernandes, Antero, Sandesc, Dorel, Arabi, Yaasen, Bumbasierevic, Vesna, Nin, Nicola, Lorente, Jose A., Piquilloud, Lise, Abroug, Fekri, McNamee, Lia, Hurtado, Javier, Bajwa, Ed, Démpaire, Gabriel, Sula, Hektor, Nunci, Lordian, Cani, Alma, Zazu, Alan, Dellera, Christian, Alejandro, Risso V., Daldin, Julio, Vinzio, Mauricio, Fernandez, Ruben O., Cardonnet, Luis P., Bettini, Lisandro R., Bisso, Mariano Carboni, Osman, Emilio M., Setten, Mariano G., Lovazzano, Pablo, Alvarez, Javier, Villar, Veronica, Pozo, Norberto C., Grubissich, Nicola, Plotnikow, Gustavo A., Vasquez, Daniela N., Ilutovich, Santiago, Tiribelli, Norberto, Chena, Ariel, Pellegrini, Carlos A., Saenz, María G., Estenssoro, Elisa, Brizuela, Matia, Gianinetto, Hernan, Gomez, Pablo E., Cerrato, Valeria I., Bezzi, Marco G., Borello, Silvina A., Loiacono, Flavia A., Fernandez, Adriana M., Knowles, Serena, Reynolds, Claire, Inskip, Deborah M., Miller, Jennene J., Kong, Jing, Whitehead, Christina, Bihari, Shailesh, Seven, Aylin, Krstevski, Amanda, Rodgers, Helen J., Millar, Rebecca T., Mckenna, Toni E., Bailey, Irene M., Hanlon, Gabrielle C., Aneman, Ander, Lynch, Joan M., Azad, Raman, Neal, John, Woods, Paul W., Roberts, Brigit L., Kol, Mark R., Wong, Helen S., Riss, Katharina C., Staudinger, Thoma, Wittebole, Xavier, Berghe, Caroline, Bulpa, Pierre A., Dive, Alain M., Verstraete, Rik, Lebbinck, Herve, Depuydt, Pieter, Vermassen, Jori, Meersseman, Philippe, Ceunen, Helga, Rosa, Jonas I., Beraldo, Daniel O., Piras, Claudio, Rampinelli, Adenilton M., Nassar, Antonio P., Mataloun, Sergio, Moock, Marcelo, Thompson, Marlus M., Gonçalves, Claudio H., Antônio, Ana Carolina P., Ascoli, Aline, Biondi, Rodrigo S., Fontenele, Danielle C., Nobrega, Danielle, Sales, Vanessa M., Shindhe, Suresh, Ismail, Dk Maizatul Aiman B. Pg Hj, Laffey, John, Beloncle, Francoi, Davies, Kyle G., Cirone, Rob, Manoharan, Venika, Ismail, Mehvish, Goligher, Ewan C., Jassal, Mandeep, Nishikawa, Erin, Javeed, Areej, Curley, Gerard, Rittayamai, Nuttapol, Parotto, Matteo, Ferguson, Niall D., Mehta, Sangeeta, Knoll, Jenny, Pronovost, Antoine, Canestrini, Sergio, Bruhn, Alejandro R., Garcia, Patricio H., Aliaga, Felipe A., Farías, Pamela A., Yumha, Jacob S., Ortiz, Claudia A., Salas, Javier E., Saez, Alejandro A., Vega, Luis D., Labarca, Eduardo F., Martinez, Felipe T., Carreño, Nicolás G., Lora, Pilar, Liu, Haitao, Liu, Ling, Tang, Rui, Luo, Xiaoming, An, Youzhong, Zhao, Huiying, Gao, Yan, Zhai, Zhe, Ye, Zheng L., Wang, Wei, Li, Wenwen, Li, Qingdong, Zheng, Ruiqiang, Yu, Wenkui, Shen, Juanhong, Li, Xinyu, Yu, Tao, Lu, Weihua, Wu, Ya, Huang, Xiao B., He, Zhenyang, Lu, Yuanhua, Han, Hui, Zhang, Fan, Sun, Renhua, Wang, Hua X., Qin, Shu H., Zhu, Bao H., Zhao, Jun, Liu, Jian, Li, Bin, Liu, Jing L., Zhou, Fa, Li, Qiong J., Zhang, Xing Y., Li-Xin, Zhou, Xin-Hua, Qiang, Jiang, Liangyan, Gao, Yuan N., Zhao, Xian Y., Li, Yuan Y., Li, Xiao L., Wang, Chunting, Yao, Qingchun, Yu, Rongguo, Chen, Kai, Shao, Huanzhang, Qin, Bingyu, Huang, Qing Q., Zhu, Wei H., Hang, Ai, Hua, Ma, Li, Yimin, Xu, Yonghao, Di, Yu, Ling, Long L., Qin, Tie H., Wang, Shou H., Qin, Junping, Han, Yi, Zhou, Suming, Vargas, Monica P., Jimenez, Juan I. Silesky, Rojas, Manuel A. 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John, Hagan, Samantha J., Wise, Matt P., Cole, Jade M., MacFie, Caroline C., Dowling, Anna T., Nin, Nicolá, Nuñez, Edgardo, Pittini, Gustavo, Rodriguez, Ruben, Imperio, María C., Santos, Cristina, França, Ana G., Ebeid, Alejandro, Deicas, Alberto, Serra, Carolina, Uppalapati, Aditya, Kamel, Ghassan, Banner-Goodspeed, Valerie M., Beitler, Jeremy R., Mukkera, Satyanarayana Reddy, Kulkarni, Shreedhar, Lee, Jarone, Mesar, Tomaz, Shinn, John O., Gomaa, Dina, Tainter, Christopher, Yeatts, Dale J., Warren, Jessica, Lanspa, Michael J., Miller, Russel R., Grissom, Colin K., Brown, Samuel M., Bauer, Philippe R., Gosselin, Ryan J., Kitch, Barrett T., Cohen, Jason E., Beegle, Scott H., Gueret, Renaud M., Tulaimat, Aiman, Choudry, Shazia, Stigler, William, Batra, Hitesh, Huff, Nidhi G., Lamb, Keith D., Oetting, Trevor W., Mohr, Nicholas M., Judy, Claine, Saito, Shigeki, Kheir, Fayez M., Kheir, Fayez, Schlichting, Adam B., Delsing, Angela, Crouch, Daniel R., Elmasri, Mary, Ismail, Dina, Dreyer, Kyle R., Blakeman, Thomas C., Baron, Rebecca M., Grijalba, Carolina Quintana, Hou, Peter C., Seethala, Raghu, Aisiku, Imo, Henderson, Galen, Frendl, Gyorgy, Hou, Sen-Kuang, Owens, Robert L., Schomer, Ashley, Bumbasirevic, Vesna, Jovanovic, Bojan, Surbatovic, Maja, Veljovic, Milic, Intensive Care Medicine, Graduate School, ACS - Heart failure & arrhythmias, AII - Inflammatory diseases, ACS - Diabetes & metabolism, ACS - Pulmonary hypertension & thrombosis, ACS - Microcirculation, Bos, L. D., Simonis, F. D., Schultz, M. J., Laffey, J. G., Mcauley, D. F., Thompson, B. T., Slutsky, A. S., Lora, F. S., Azevedo, L. C., Ranero, J. L., Hashemian, S. M., Zeggwagh, A. A., Heunks, L. M., Laake, J. H., Palo, J. E., Lorente, J. A., Mcnamee, L., Dempaire, G., Alejandro, R. V., Fernandez, R. O., Cardonnet, L. P., Bettini, L. R., Bisso, M. C., Osman, E. M., Setten, M. G., Pozo, N. C., Plotnikow, G. A., Vasquez, D. N., Pellegrini, C. A., Saenz, M. G., Gomez, P. E., Cerrato, V. I., Bezzi, M. G., Borello, S. A., Loiacono, F. A., Fernandez, A. M., Inskip, D. M., Miller, J. J., Rodgers, H. J., Millar, R. T., Mckenna, T. E., Bailey, I. M., Hanlon, G. C., Lynch, J. M., Woods, P. W., Roberts, B. L., Kol, M. R., Wong, H. S., Riss, K. C., Bulpa, P. A., Dive, A. M., Rosa, J. I., Beraldo, D. O., Rampinelli, A. M., Nassar, A. P., Thompson, M. M., Goncalves, C. H., Antonio, A. C. P., Biondi, R. S., Fontenele, D. C., Sales, V. M., Ismail, D. M. A. B. P. H., Davies, K. G., Goligher, E. C., Ferguson, N. D., Bruhn, A. R., Garcia, P. H., Aliaga, F. A., Farias, P. A., Yumha, J. S., Ortiz, C. A., Salas, J. E., Saez, A. A., Vega, L. D., Labarca, E. F., Martinez, F. T., Carreno, N. G., Ye, Z. L., Wu, Y. Q., Huang, X. B., Wang, H. X., Qin, S. H., Zhu, B. H., Liu, J. L., Zhou, F. C., Li, Q. J., Zhang, X. Y., Gao, Y. N., Zhao, X. Y., Li, Y. Y., Li, X. L., Huang, Q. Q., Zhu, W. H., Hang, A. Y., Hua, M. X., Di, Y. D., Ling, L. L., Qin, T. H., Wang, S. H., Vargas, M. P., Jimenez, J. I. S., Rojas, M. A. G., Solis-Quesada, J. E., Ramirez-Alfaro, C. M., Maca, J., Villamagua, B. G., Chiche, J. -D., Arnal, J. -M., Au, S. -M., Beduneau, G., Zogheib, E. H., Santoli, F. L., Besset, S. L., Gelee, B., Danin, P. -E., Crova, P. J., Phan, N. T., Badie, J. C., Herbrecht, J. -E., Declercq, P. -L. M., Rigaud, J. -P., Zein, S. O., Richecoeur, J. R., Combaux, D. M., Lemoal, C., Sauvadet, E. P., Guerin, C., Krassler, J., Schafer, S., Zacharowski, K. D., Reske, A. W., Hopf, H. -B. 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R., George, F. G., Aguirre, J. S., Buensuseso, J. A., Bruns, M. M., Schouten, J. A., Van Wezel, H. M., Heines, S. J., Buise, M. P., Goodson, J. C., Browne, T. S., Hutchison, R. A., Bailey, M. B., Hacking, D. J., Andersen, F. H., Dolva, M. S., Noremark, K. A. L., Soreide, E., Sjobo, B. A., Guttormsen, A. B., Yoshido, H. H. L., Aguilar, R. Z., Oscanoa, F. A. M., Alisasis, A. U., Robles, J. B., Pasanting-Lim, R. A. B., Tan, B. C., Coxo, C. M., Alvarez, A. M., Oliveira, B. S., Montanha, G. M., Barros, N. C., Pereira, C. S., Messias, A. M., Monteiro, J. M., Araujo, A. M., Catorze, N. T., Marum, S. M., Bouw, M. J., Gomes, R. M., Brito, V. A., Estilita, J. M., Barros, F. M., Serra, I. M., Martinho, A. M., Tomescu, D. R., Bedreag, O. H., Corneci, D. E., Negoita, S. L., Gritsan, A. I., Gazenkampf, A. A., Albarrak, M. M., Mustafa, G. M., Maghrabi, K. A., Aisa, T. M., Jabbary, A. S. A., Arabi, Y. M., Trinidad, O. A., Dorzi, H. M. A., Tabhan, E. E., Lopez-Delgado, J. C., Albaiceta, G. M., Ruiz-Aguilar, A. L., Claraco-Vega, L. M., Soler, J. A., Prieto-Gonzalez, M., Lopez-Messa, J. B., Perez, M. P., Perez, C. P., Allue, R. M., Ibanez-Santacruz, M., Pintado, M. C., Depablo, R., Gomez, P. R. A., Ruiz, S. R., Moles, S. I., Jurado, M. T., Piacentini, E. A., Cheng, M. P., Losada, E. P., Yuste, L. J., Cazorla-Barranquero, F. G., Alonso, J. G., Alda, R. S., Algaba, A., Marcos, D. P., Montero, L. A., Para, L. H., Sanchez, R. J., Navalpotro, M. A. B., Abad, R. D., Gonzalez, R. M., Toribio, D. P., Castro, A. G., Artiga, M. J. D., Roser, T. P., Olga, M. F., Curto, E. G., Sanchez, R. M., Imma, V. P., Elisabet, G. M., Pellicer, A. M., Rodriguez, L. L., Sanchez-Ballesteros, J., Gonzalez-Salamanca, A., Jimenez, A. G., Huerta, F. P., Diaz, J. C. J. S., Lopez, E. B., Moya, D. D. L., Alfonso, A. A. T., Luis, P. S. E., Cesar, P. S., Rafael, S. I., Virgilio, C. G., Recio, N. N., Adamsson, R. O., Rylander, C. C., Broman, L. M., Schioler, F., Tibblin, A. O., Eriksson, K. E., Nunes, S. L., Morin, A. -K., Zender, H. O., Souissi, A. B., Girgin, N. K., Unal, N., Meco, B. C., Akyol, O. O., Derman, S. S., Mcauley, D., Humphreys, S. K., Raj, A. S., Fawkes, D. A., Thomas, R. R. J. M., Smith, M. J., Hormis, A. P., Kannan, S. G., O'Neill, O., Scott, C. J., Ellis, H. E., Mckechnie, S., Hutton, P. J., Ditomasso, N. N., Vitale, M. N., Griffin, R. O., Dean, M. N., Cranshaw, J. H., Willett, E. L., Preez, P. D., Williams, A. J., Degordoa, L. O. -R., Chau, S. K., Mccalman, K. H., Allan, R. M., Wrathall, D. W., Irvine, D. A., Zantua, K. S., Adams, J. C., Burtenshaw, A. J., Sellors, G. P., Welters, I. D., Williams, K. E., Hessell, R. J., Oldroyd, M. G., Battle, C. E., O'Kane, S. C., Frigyik, A. D., Careless, J. P., May, M. M., Trinder, T. J., Hagan, S. J., Wise, M. P., Cole, J. M., Macfie, C. C., Dowling, A. T., Nunez, E., Imperio, M. C., Franca, A. G., Banner-Goodspeed, V. M., Beitler, J. R., Mukkera, S. R., Shinn, J. O., Yeatts, D. J., Lanspa, M. J., Miller, R. R., Grissom, C. K., Brown, S. M., Bauer, P. R., Gosselin, R. J., Kitch, B. T., Cohen, J. E., Beegle, S. H., Gueret, R. M., Huff, N. G., Lamb, K. D., Oetting, T. W., Mohr, N. M., Kheir, F. M., Schlichting, A. B., Crouch, D. R., Dreyer, K. R., Blakeman, T. C., Baron, R. M., Grijalba, C. Q., Hou, P. C., Hou, S. -K., and Owens, R. L.

Subjects
Male, ARDS, medicine.medical_treatment, lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], ARDS reassessment, ARDS Survival, Berlin criteria ARDS, Persisting ARDS, Critical Care and Intensive Care Medicine, assisted ventilation, 0302 clinical medicine, Risk Factors, 030212 general & internal medicine, risk factor, Adult, Tidal volume, comparative study, education.field_of_study, Respiratory Distress Syndrome, Mortality rate, Remission Induction, tidal volume, artificial ventilation, clinical trial, immunosuppressive treatment, adult respiratory distress syndrome, Middle Aged, Monte Carlo method, medicine.anatomical_structure, classification, positive end expiratory pressure, Cardiology, Disease Progression, SOFA score, disease severity, Female, Adult, medicine.medical_specialty, Population, disease classification, Article, NO, 03 medical and health sciences, remission, length of stay, Anesthesiology, Internal medicine, medicine, pneumonia, Sequential Organ Failure Assessment Score, Humans, human, education, Aged, Mechanical ventilation, hospital mortality, Lung, business.industry, Risk Factor, disease association, Respiratory Distress Syndrome, Adult, medicine.disease, major clinical study, mortality, Respiration, Artificial, breathing rate, 030228 respiratory system, disease exacerbation, business
Abstract

Purpose: To evaluate patients with resolved versus confirmed ARDS, identify subgroups with substantial mortality risk, and to determine the utility of day 2 ARDS reclassification. Methods: Our primary objective, in this secondary LUNG SAFE analysis, was to compare outcome in patients with resolved versus confirmed ARDS after 24 h. Secondary objectives included identifying factors associated with ARDS persistence and mortality, and the utility of day 2 ARDS reclassification. Results: Of 2377 patients fulfilling the ARDS definition on the first day of ARDS (day 1) and receiving invasive mechanical ventilation, 503 (24%) no longer fulfilled the ARDS definition the next day, 52% of whom initially had moderate or severe ARDS. Higher tidal volume on day 1 of ARDS was associated with confirmed ARDS [OR 1.07 (CI 1.01–1.13), P = 0.035]. Hospital mortality was 38% overall, ranging from 31% in resolved ARDS to 41% in confirmed ARDS, and 57% in confirmed severe ARDS at day 2. In both resolved and confirmed ARDS, age, non-respiratory SOFA score, lower PEEP and P/F ratio, higher peak pressure and respiratory rate were each associated with mortality. In confirmed ARDS, pH and the presence of immunosuppression or neoplasm were also associated with mortality. The increase in area under the receiver operating curve for ARDS reclassification on day 2 was marginal. Conclusions: ARDS, whether resolved or confirmed at day 2, has a high mortality rate. ARDS reclassification at day 2 has limited predictive value for mortality. The substantial mortality risk in severe confirmed ARDS suggests that complex interventions might best be tested in this population. Trial Registration: ClinicalTrials.gov NCT02010073. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature and ESICM.

Published
2018

30. Outcomes of Patients Presenting with Mild Acute Respiratory Distress Syndrome: Insights from the LUNG SAFE Study

Author

Pham, Tài, Serpa Neto, Ary, Pelosi, Paolo, Laffey, John Gerard, De Haro, Candelaria, Lorente, Jose Angel, Bellani, Giacomo, Fan, Eddy, Brochard, Laurent Jean, Pesenti, Antonio, Schultz, Marcus Josephus, Artigas, Antonio, Esteban, Andres, Gattinoni, Luciano, van Haren, Frank, Larsson, Anders, McAuley, Daniel F, Ranieri, Marco, Rubenfeld, Gordon, Thompson, B Taylor, Wrigge, Hermann, Slutsky, Arthur S, Rios, Fernando, Van Haren, Frank, Sottiaux, Thierry, Depuydt, Pieter, Lora, Fredy S, Azevedo, Luciano Cesar, Bugedo, Guillermo, Qiu, Haibo, Gonzalez, Marcos, Silesky, Juan, Cerny, Vladimir, Nielsen, Jonas, Jibaja, Manuel, Matamis, Dimitrios, Ranero, Jorge Luis, Amin, Pravin, Hashemian, S M, Clarkson, Kevin, Kurahashi, Kiyoyasu, Villagomez, Asisclo, Zeggwagh, Amine Ali, Heunks, Leo M, Laake, Jon Henrik, Palo, Jose Emmanuel, do Vale Fernandes, Antero, Sandesc, Dorel, Arabi, Yaasen, Bumbasierevic, Vesna, Nin, Nicolas, Piquilloud, Lise, Abroug, Fekri, McNamee, Lia, Hurtado, Javier, Bajwa, Ed, Démpaire, Gabriel, Sula, Hektor, Nunci, Lordian, Cani, Alma, Zazu, Alan, Dellera, Christian, Insaurralde, Carolina S, Alejandro, Risso V, Daldin, Julio, Vinzio, Mauricio, Fernandez, Ruben O, Cardonnet, Luis P, Bettini, Lisandro R, Bisso, Mariano Carboni, Osman, Emilio M, Setten, Mariano G, Lovazzano, Pablo, Alvarez, Javier, Villar, Veronica, Pozo, Norberto C, Grubissich, Nicolas, Plotnikow, Gustavo A, Vasquez, Daniela N, Ilutovich, Santiago, Tiribelli, Norberto, Chena, Ariel, Pellegrini, Carlos A, Saenz, María G, Estenssoro, Elisa, Brizuela, Matias, Gianinetto, Hernan, Gomez, Pablo E, Cerrato, Valeria I, Bezzi, Marco G, Borello, Silvina A, Loiacono, Flavia A, Fernandez, Adriana M, Knowles, Serena, Reynolds, Claire, Inskip, Deborah M, Miller, Jennene J, Kong, Jing, Whitehead, Christina, Bihari, Shailesh, Seven, Aylin, Krstevski, Amanda, Rodgers, Helen J, Millar, Rebecca T, Mckenna, Toni E, Bailey, Irene M, Hanlon, Gabrielle C, Aneman, Anders, Lynch, Joan M, Azad, Raman, Neal, John, 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Goodson, J.C., Browne, T.S., Hutchison, R.A., Bailey, M.B., McArthur, C., Hacking, D.J., Andersen, F.H., Dolva, M.S., Noremark, K.A.L., Søreide, E., Sjøbø, B.Å., Guttormsen, A.B., Leon Yoshido, H.H., Aguilar, R.Z., Montes Oscanoa, F.A., Alisasis, A.U., Robles, J.B., Pasanting-Lim, R.A.B., Tan, B.C., Coxo, C.M., Alvarez, A.M., Oliveira, B.S., Montanha, G.M., Barros, N.C., Pereira, C.S., Messias, A.M., Monteiro, J.M., Araujo, A.M., Catorze, N.T., Marum, S.M., Bouw, M.J., Gomes, R.M., Brito, V.A., Estilita, J.M., Barros, F.M., Serra, I.M., Martinho, A.M., Tomescu, D.R., Bedreag, O.H., Corneci, D.E., Negoita, S.I., Gritsan, A.I., Gazenkampf, A.A., Albarrak, M.M., Mustafa, G.M., Maghrabi, K.A., Aisa, T.M., Al Jabbary, A.S., Arabi, Y.M., Trinidad, O.A., Al Dorzi, H.M., Tabhan, E.E., Lopez-Delgado, J.C., Albaiceta, G.M., Ruiz-Aguilar, A.L., Claraco-Vega, L.M., Soler, J.A., Prieto-González, M., López-Messa, J.B., Perez, M.P., Perez, C.P., Ibañez-Santacruz, M., Pintado, M.C., Aroa Gómez, P.R., Ruiz, S.R., Moles, S.I., Piacentini, E.A., Cheng, M.P., Losada, E.P., Yuste, L.J., Cazorla-Barranquero, F.G., Alonso, J.G., Alda, R.S., Algaba, Á., Montero, L.A., Para, L.H., Sanchez, R.J., Blasco Navalpotro, M.A., Abad, R.D., González, R.M., Toribio, D.P., Castro, A.G., Artiga, M.J.D., Roser, T.P., Olga, M.F., Curto, E.G., Sánchez, R.M., Imma, V.P., Elisabet, G.M., Pellicer, A.M., Rodriguez, L.L., Sánchez-Ballesteros, J., González-Salamanca, Á., Jimenez, A.G., Huerta, F.P., Sotillo Diaz, J.C.J., Lopez, E.B., Llinares Moya, D.D., Tallet Alfonso, A.A., Eugenio Luis, P.S., Cesar, P.S., Rafael, S.I., Virgilio, C.G., Recio, N.N., Adamsson, R.O., Rylander, C.C., Broman, L.M., Schiöler, F., Tibblin, A.O., Eriksson, K.E., Nunes, S.L., Morin, A.-K., Zender, H.O., Souissi, A.B., Girgin, N.K., Ünal, N., Meco, B.C., Akyol, O.O., Derman, S.S., McAuley, D., Humphreys, S.K., Raj, A.S., Fawkes, D.A., Jha, R.R., Smith, M.J., Hormis, A.P., Kannan, S.G., Scott, C.J., Ellis, H.E., Hutton, P.J., Di Tomasso, N.N., Vitale, M.N., Griffin, R.O., Dean, M.N., Cranshaw, J.H., Willett, E.L., Preez, P.D., Williams, A.J., Chau, S.K., Mccalman, K.H., Allan, R.M., Wrathall, D.W., Irvine, D.A., Zantua, K.S., Adams, J.C., Burtenshaw, A.J., Sellors, G.P., Welters, I.D., Williams, K.E., Hessell, R.J., Oldroyd, M.G., Battle, C.E., Okane, S.C., Frigyik, A.D., Careless, J.P., May, M.M., Trinder, T.J., Hagan, S.J., Cole, J.M., MacFie, C.C., Dowling, A.T., Nuñez, E., Imperio, M.C., França, A.G., Banner-Goodspeed, V.M., Beitler, J.R., Mukkera, S.R., Shinn, J.O., 3rd and Gomaa, D., Yeatts, D.J., Lanspa, M.J., Miller, R.R., Grissom, C.K., Brown, S.M., Bauer, P.R., Gosselin, R.J., Kitch, B.T., Cohen, J.E., Beegle, S.H., Gueret, R.M., Huff, N.G., Lamb, K.D., Oetting, T.W., Mohr, N.M., Kheir, F.M., Schlichting, A.B., Crouch, D.R., Dreyer, K.R., Baron, R.M., Grijalba, C.Q., Hou, P.C., Hou, S.-K., Owens, R.L., LUNG SAFE Investigators* and the European Society of Intensive Care Medicine Trials Group, Pham, 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A, Salas, Javier E, Saez, Alejandro A, Vega, Luis D, Labarca, Eduardo F, Martinez, Felipe T, Carreño, Nicolás G, Lora, Pilar, Liu, Haitao, Liu, Ling, Tang, Rui, Luo, Xiaoming, An, Youzhong, Zhao, Huiying, Gao, Yan, Zhai, Zhe, Ye, Zheng L, Wang, Wei, Li, Wenwen, Li, Qingdong, Zheng, Ruiqiang, Yu, Wenkui, Shen, Juanhong, Li, Xinyu, Yu, Tao, Lu, Weihua, Wu, Ya Q, Huang, Xiao B, He, Zhenyang, Lu, Yuanhua, Han, Hui, Zhang, Fan, Sun, Renhua, Wang, Hua X, Qin, Shu H, Zhu, Bao H, Zhao, Jun, Liu, Jian, Li, Bin, Liu, Jing L, Zhou, Fa C, Li, Qiong J, Zhang, Xing Y, Li-Xin, Zhou, Xin-Hua, Qiang, Jiang, Liangyan, Gao, Yuan N, Zhao, Xian Y, Li, Yuan Y, Li, Xiao L, Wang, Chunting, Yao, Qingchun, Yu, Rongguo, Chen, Kai, Shao, Huanzhang, Qin, Bingyu, Huang, Qing Q, Zhu, Wei H, Hang, Ai Y, Hua, Ma X, Li, Yimin, Xu, Yonghao, Di, Yu D, Ling, Long L, Qin, Tie H, Wang, Shou H, Qin, Junping, Han, Yi, Zhou, Suming, Vargas, Monica P, Silesky Jimenez, Juan I, González Rojas, Manuel A, Solis-Quesada, Jaime E, Ramirez-Alfaro, Christian M, Máca, Jan, Sklienka, Peter, Gjedsted, Jakob, Christiansen, Aage, Villamagua, Boris G, Llano, Miguel, Burtin, Philippe, Buzancais, Gautier, Beuret, Pascal, Pelletier, Nicola, Mortaza, Satar, Mercat, Alain, Chelly, Jonathan, Jochmans, Sébastien, Terzi, Nicola, Daubin, Cédric, Carteaux, Guillaume, de Prost, Nicola, Chiche, Jean-Daniel, Daviaud, Fabrice, Fartoukh, Muriel, Barberet, Guillaume, Biehler, Jerome, Dellamonica, Jean, Doyen, Deni, Arnal, Jean-Michel, Briquet, Anai, Hraiech, Sami, Papazian, Laurent, Follin, Arnaud, Roux, Damien, Messika, Jonathan, Kalaitzis, Evangelo, Dangers, Laurence, Combes, Alain, Au, Siu-Ming, Béduneau, Gaetan, Carpentier, Dorothée, Zogheib, Elie H, Dupont, Herve, Ricome, Sylvie, Santoli, Francesco L, Besset, Sebastien L, Michel, Philippe, Gelée, Bruno, Danin, Pierre-Eric, Goubaux, Bernard, Crova, Philippe J, Phan, Nga T, Berkelmans, Frantz, Badie, Julio C, Tapponnier, Romain, Gally, Josette, Khebbeb, Samy, Herbrecht, Jean-Etienne, Schneider, Franci, Declercq, Pierre-Louis M, Rigaud, Jean-Philippe, Duranteau, Jacque, Harrois, Anatole, Chabanne, Russell, Marin, Julien, Bigot, Charlene, Thibault, Sandrine, Ghazi, Mohammed, Boukhazna, Messabi, Zein, Salem Ould, Richecoeur, Jack R, Combaux, Daniele M, Grelon, Fabien, Moal, Charlene Le, Sauvadet, Elise P, Robine, Adrien, Lemiale, Virginie, Reuter, Danielle, Dres, Martin, Demoule, Alexandre, Goldgran-Toledano, Dany, Baboi, Loredana, Guérin, Claude, Lohner, Ralph, Kraßler, Jen, Schäfer, Susanne, Zacharowski, Kai D, Meybohm, Patrick, Reske, Andreas W, Simon, Philipp, Hopf, Hans-Bernd F, Schuetz, Michael, Baltus, Thoma, Papanikolaou, Metaxia N, Papavasilopoulou, Theonymfi G, Zacharas, Giannis A, Ourailogloy, Vasili, Mouloudi, Eleni K, Massa, Eleni V, Nagy, Eva O, Stamou, Electra E, Kiourtzieva, Ellada V, Oikonomou, Marina A, Avila, Luis E, Cortez, Cesar A, Citalán, Johanna E, Jog, Sameer A, Sable, Safal D, Shah, Bhagyesh, Gurjar, Mohan, Baronia, Arvind K, Memon, Mohammedfaruk, Muthuchellappan, Radhakrishnan, Ramesh, Venkatapura J, Shenoy, Anitha, Unnikrishnan, Ramesh, Dixit, Subhal B, Rhayakar, Rachana V, Ramakrishnan, Nagarajan, Bhardwaj, Vallish K, Mahto, Heera L, Sagar, Sudha V, Palaniswamy, Vijayanand, Ganesan, Deeban, Hashemian, Seyed Mohammadreza, Jamaati, Hamidreza, Heidari, Farshad, Meaney, Edel A, Nichol, Alistair, Knapman, Karl M, O'Croinin, Donall, Dunne, Eimhin S, Breen, Dorothy M, Clarkson, Kevin P, Jaafar, Rola F, Dwyer, Rory, Amir, Fahd, Ajetunmobi, Olaitan O, O'Muircheartaigh, Aogan C, Black, Colin S, Treanor, Nuala, Collins, Daniel V, Altaf, Wahid, Zani, Gianluca, Fusari, Maurizio, Spadaro, Savino, Volta, Carlo A, Graziani, Romano, Brunettini, Barbara, Palmese, Salvatore, Formenti, Paolo, Umbrello, Michele, Lombardo, Andrea, Pecci, Elisabetta, Botteri, Marco, Savioli, Monica, Protti, Alessandro, Mattei, Alessia, Schiavoni, Lorenzo, Tinnirello, Andrea, Todeschini, Manuel, Giarratano, Antonino, Cortegiani, Andrea, Sher, Sara, Rossi, Anna, Antonelli, Massimo M, Montini, Luca M, Casalena, Paolo, Scafetti, Sergio, Panarello, Giovanna, Occhipinti, Giovanna, Patroniti, Nicolò, Pozzi, Matteo, Biscione, Roberto R, Poli, Michela M, Raimondi, Ferdinando, Albiero, Daniela, Crapelli, Giulia, Beck, Eduardo, Pota, Vincenzo, Schiavone, Vincenzo, Molin, Alexandre, Tarantino, Fabio, Monti, Giacomo, Frati, Elena, Mirabella, Lucia, Cinnella, Gilda, Fossali, Tommaso, Colombo, Riccardo, Pattarino, Pierpaolo Terragni Ilaria, Mojoli, Francesco, Braschi, Antonio, Borotto, Erika E, Cracchiolo, Andrea N, Palma, Daniela M, Raponi, Francesco, Foti, Giuseppe, Vascotto, Ettore R, Coppadoro, Andrea, Brazzi, Luca, Floris, Leda, Iotti, Giorgio A, Venti, Aaron, Yamaguchi, Osamu, Takagi, Shunsuke, Maeyama, Hiroki N, Watanabe, Eizo, Yamaji, Yoshihiro, Shimizu, Kazuyoshi, Shiozaki, Kyoko, Futami, Satoru, Ryosuke, Sekine, Saito, Koji, Kameyama, Yoshinobu, Ueno, Keiko, Izawa, Masayo, Okuda, Nao, Suzuki, Hiroyuki, Harasawa, Tomofumi, Nasu, Michitaka, Takada, Tadaaki, Ito, Fumihito, Nunomiya, Shin, Koyama, Kansuke, Abe, Toshikazu, Andoh, Kohkichi, Kusumoto, Kohei, Hirata, Akira, Takaba, Akihiro, Kimura, Hiroyasu, Matsumoto, Shuhei, Higashijima, Ushio, Honda, Hiroyuki, Aoki, Nobumasa, Imai, Hiroshi, Ogino, Yasuaki, Mizuguchi, Ichiko, Ichikado, Kazuya, Nitta, Kenichi, Mochizuki, Katsunori, Hashida, Tomoaki, Tanaka, Hiroyuki, Nakamura, Tomoyuki, Niimi, Daisuke, Ueda, Takeshi, Kashiwa, Yozo, Uchiyama, Akinori, Sabelnikovs, Oleg, Oss, Peteri, Haddad, Youssef, Liew, Kong Y, Ñamendys-Silva, Silvio A, Jarquin-Badiola, Yves D, Sanchez-Hurtado, Luis A, Gomez-Flores, Saira S, Marin, Maria C, Villagomez, Asisclo J, Lemus, Jordana S, Fierro, Jonathan M, Cervantes, Mavy Ramirez, Mejia, Francisco Javier Flore, Dector, Dulce, Rojas, Alejandro, Gonzalez, Daniel R, Estrella, Claudia R, Sanchez-Medina, Jorge R, Ramirez-Gutierrez, Alvaro, George, Fernando G, Aguirre, Janet S, Buensuseso, Juan A, Poblano, Manuel, Dendane, Tarek, Balkhi, 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Monteiro, Jorge M, Araujo, Ana M, Catorze, Nuno T, Marum, Susan M, Bouw, Maria J, Gomes, Rui M, Brito, Vania A, Castro, Silvia, Estilita, Joana M, Barros, Filipa M, Serra, Isabel M, Martinho, Aurelia M, Tomescu, Dana R, Marcu, Alexandra, Bedreag, Ovidiu H, Papurica, Mariu, Corneci, Dan E, Negoita, Silvius Ioan, Grigoriev, Evgeny, Gritsan, Alexey I, Gazenkampf, Andrey A, Almekhlafi, Ghaleb, Albarrak, Mohamad M, Mustafa, Ghanem M, Maghrabi, Khalid A, Salahuddin, Nawal, Aisa, Tharwat M, Al Jabbary, Ahmed S, Tabhan, Edgardo, Arabi, Yaseen M, Trinidad, Olivia A, Al Dorzi, Hasan M, Tabhan, Edgardo E, Bolon, Stefan, Smith, Oliver, Mancebo, Jordi, Aguirre-Bermeo, Hernan, Lopez-Delgado, Juan C, Esteve, Francisco, Rialp, Gemma, Forteza, Catalina, Albaiceta, Guillermo M, De Cima-Iglesias, Sara, Seoane-Quiroga, Leticia, Ceniceros-Barros, Alexandra, Ruiz-Aguilar, Antonio L, Claraco-Vega, Luis M, Soler, Juan Alfonso, Del Carmen Lorente, Maria, Hermosa, Cecilia, Gordo, Federico, Prieto-González, Miryam, López-Messa, Juan B, Perez, Manuel P, Perez, Cesar P, Montoiro Allue, Raquel, Roche-Campo, Ferran, Ibañez-Santacruz, Marco, Temprano, Susana, Pintado, Maria C, De Pablo, Raul, Aroa Gómez, Pilar Ricart, Ruiz, Silvia Rodriguez, Moles, Silvia Iglesia, Arizmendi, Alfon, Piacentini, Enrique A, Franco, Nieve, Honrubia, Teresa, Cheng, Meisy Perez, Losada, Elena Perez, Blanco, Javier, Yuste, Luis J, Carbayo-Gorriz, Cecilia, Cazorla-Barranquero, Francisca G, Alonso, Javier G, Alda, Rosa S, Algaba, Ángela, Navarro, Gonzalo, Cereijo, Enrique, Diaz-Rodriguez, Esther, Pastor Marcos, Diego, Montero, Laura Alvarez, Para, Luis Herrera, Sanchez, Roberto Jimenez, Blasco Navalpotro, Miguel Angel, Abad, Ricardo Diaz, González, Raquel Montiel, Toribio, Dácil Parrilla, Castro, Alejandro G, Artiga, Maria Jose D, Penuelas, Oscar, Roser, Tomas P, Olga, Moreno F, Curto, Elena Gallego, Sánchez, Rocío Manzano, Imma, Vallverdu P, Elisabet, Garcia M, Claverias, Laura, Magret, Monica, Pellicer, Ana M, Rodriguez, Lucia L, Sánchez-Ballesteros, Jesú, González-Salamanca, Ángela, Jimenez, Antonio G, Huerta, Francisco P, Sotillo Diaz, Juan Carlos J, Lopez, Esther Bermejo, Llinares Moya, David D, Tallet Alfonso, Alec A, Eugenio Luis, Palazon Sanchez, Cesar, Palazon Sanchez, Rafael, Sánchez I, Virgilio, Corcoles G, Recio, Noelia N, Adamsson, Richard O, Rylander, Christian C, Holzgraefe, Bernhard, Broman, Lars M, Wessbergh, Joanna, Persson, Linnea, Schiöler, Fredrik, Kedelv, Han, Tibblin, Anna Oscarsson, Appelberg, Henrik, Hedlund, Lar, Helleberg, Johan, Eriksson, Karin E, Glietsch, Rita, Larsson, Nikla, Nygren, Ingela, Nunes, Silvia L, Morin, Anna-Karin, Kander, Thoma, Adolfsson, Anne, Zender, Hervé O, Leemann-Refondini, Corinne, Elatrous, Souheil, Bouchoucha, Slaheddine, Chouchene, Imed, Ouanes, Islem, Souissi, Asma Ben, Kamoun, Salma, Demirkiran, Oktay, Aker, Mustafa, Erbabacan, Emre, Ceylan, Ilkay, Girgin, Nermin Kelebek, Ozcelik, Menekse, Ünal, Necmettin, Meco, Basak Ceyda, Akyol, Onat O, Derman, Suleyman S, Kennedy, Barry, Parhar, Ken, Srinivasa, Latha, McAuley, Danny, Hopkins, Phil, Mellis, Clare, Kakar, Vivek, Hadfield, Dan, Vercueil, Andre, Bhowmick, Kaushik, Humphreys, Sally K, Ferguson, Andrew, Mckee, Raymond, Raj, Ashok S, Fawkes, Danielle A, Watt, Philip, Twohey, Linda, Jha, Rajeev R, Thomas, Matthew, Morton, Alex, Kadaba, Varsha, Smith, Mark J, Hormis, Anil P, Kannan, Santhana G, Namih, Miriam, Reschreiter, Henrik, Camsooksai, Julie, Kumar, Alek, Rugonfalvi, Szabolc, Nutt, Christopher, Oneill, Orla, Seasman, Colette, Dempsey, Ged, Scott, Christopher J, Ellis, Helen E, Mckechnie, Stuart, Hutton, Paula J, Di Tomasso, Nora N, Vitale, Michela N, Griffin, Ruth O, Dean, Michael N, Cranshaw, Julius H, Willett, Emma L, Ioannou, Nichola, Gillis, Sarah, Csabi, Peter, Macfadyen, Rosaleen, Dawson, Heidi, Preez, Pieter D, Williams, Alexandra J, Boyd, Owen, Ortiz-Ruiz de Gordoa, Laura, Bramall, Jon, Symmonds, Sophie, Chau, Simon K, Wenham, Tim, Szakmany, Tama, 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S, Pintado, M, De Pablo, R, Aroa Gomez, P, Ruiz, S, Moles, S, Arizmendi, A, Piacentini, E, Franco, N, Honrubia, T, Cheng, M, Losada, E, Blanco, J, Yuste, L, Carbayo-Gorriz, C, Cazorla-Barranquero, F, Alonso, J, Alda, R, Algaba, A, Navarro, G, Cereijo, E, Diaz-Rodriguez, E, Pastor Marcos, D, Montero, L, Para, L, Sanchez, R, Blasco Navalpotro, M, Abad, R, Gonzalez, R, Toribio, D, Castro, A, Artiga, M, Penuelas, O, Roser, T, Olga, M, Curto, E, Imma, V, Elisabet, G, Claverias, L, Magret, M, Pellicer, A, Rodriguez, L, Sanchez-Ballesteros, J, Gonzalez-Salamanca, A, Jimenez, A, Huerta, F, Sotillo Diaz, J, Lopez, E, Llinares Moya, D, Tallet Alfonso, A, Eugenio Luis, P, Cesar, P, Rafael, S, Virgilio, C, Recio, N, Adamsson, R, Rylander, C, Holzgraefe, B, Broman, L, Wessbergh, J, Persson, L, Schioler, F, Kedelv, H, Tibblin, A, Appelberg, H, Hedlund, L, Helleberg, J, Eriksson, K, Glietsch, R, Larsson, N, Nygren, I, Nunes, S, Morin, A, Kander, T, Adolfsson, A, Zender, H, Leemann-Refondini, C, 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Subjects
Male, Internationality, Respiratory Distress Syndrome, Adult, adult respiratory distress syndrome, Middle Aged, Severity of Illness Index, Patient Outcome Assessment, Prospective Studie, Anesthesiology and Pain Medicine, Settore MED/41 - ANESTESIOLOGIA, ARDS, Female, Hospital Mortality, Acute Respiratory Distress Syndrome, Human
Abstract

Editor's Perspective What We Already Know about This Topic Hospital mortality in acute respiratory distress syndrome is approximately 40%, but mortality and trajectory in "mild" acute respiratory distress syndrome (classified only since 2012) are unknown, and many cases are not detected What This Article Tells Us That Is New Approximately 80% of cases of mild acute respiratory distress syndrome persist or worsen in the first week; in all cases, the mortality is substantial (30%) and is higher (37%) in those in whom the acute respiratory distress syndrome progresses Background: Patients with initial mild acute respiratory distress syndrome are often underrecognized and mistakenly considered to have low disease severity and favorable outcomes. They represent a relatively poorly characterized population that was only classified as having acute respiratory distress syndrome in the most recent definition. Our primary objective was to describe the natural course and the factors associated with worsening and mortality in this population. Methods: This study analyzed patients from the international prospective Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE) who had initial mild acute respiratory distress syndrome in the first day of inclusion. This study defined three groups based on the evolution of severity in the first week: "worsening" if moderate or severe acute respiratory distress syndrome criteria were met, "persisting" if mild acute respiratory distress syndrome criteria were the most severe category, and "improving" if patients did not fulfill acute respiratory distress syndrome criteria any more from day 2. Results: Among 580 patients with initial mild acute respiratory distress syndrome, 18% (103 of 580) continuously improved, 36% (210 of 580) had persisting mild acute respiratory distress syndrome, and 46% (267 of 580) worsened in the first week after acute respiratory distress syndrome onset. Global in-hospital mortality was 30% (172 of 576; specifically 10% [10 of 101], 30% [63 of 210], and 37% [99 of 265] for patients with improving, persisting, and worsening acute respiratory distress syndrome, respectively), and the median (interquartile range) duration of mechanical ventilation was 7 (4, 14) days (specifically 3 [2, 5], 7 [4, 14], and 11 [6, 18] days for patients with improving, persisting, and worsening acute respiratory distress syndrome, respectively). Admissions for trauma or pneumonia, higher nonpulmonary sequential organ failure assessment score, lower partial pressure of alveolar oxygen/fraction of inspired oxygen, and higher peak inspiratory pressure were independently associated with worsening. Conclusions: Most patients with initial mild acute respiratory distress syndrome continue to fulfill acute respiratory distress syndrome criteria in the first week, and nearly half worsen in severity. Their mortality is high, particularly in patients with worsening acute respiratory distress syndrome, emphasizing the need for close attention to this patient population.

Published
2019

31. Noninvasive Ventilation of Patients with Acute Respiratory Distress Syndrome: Insights from the LUNG SAFE Study

Author

Bellani, Giacomo, Laffey, John G., Pham, Tai, Madotto, Fabiana, Fan, Eddy, Brochard, Laurent, Esteban, Andres, Gattinoni, Luciano, Bumbasirevic, Vesna, Piquilloud, Lise, Van Haren, Frank, Larsson, Anders, McAuley, Daniel F., Bauer, Philippe R., Arabi, Yaseen M., Ranieri, Marco, Antonelli, Massimo, Rubenfeld, Gordon D., Taylor Thompson, B., Wrigge, Hermann, Slutsky, Arthur S., Pesenti, Antonio, Rios F, Van Haren F, Sottiaux T, Depuydt P, Lora FS, Azevedo LC, Fan E, Bugedo G, Qiu H, Gonzalez M, Silesky J, Cerny V, Nielsen J, Jibaja M, Pham T, Wrigge H, Matamis D, Ranero JL, Amin P, Hashemian SM, Clarkson K, Bellani G, Kurahashi K, Villagomez A, Zeggwagh AA, Heunks LM, Laake JH, Palo JE, do Vale Fernandes A, Sandesc D, Arabi Y, Bumbasierevic V, Nin N, Lorente JA, Larsson A, Piquilloud L, Abroug F, McAuley DF, McNamee L, Hurtado J, Bajwa E, Démpaire G, Francois GM, Sula H, Nunci L, Cani A, Zazu A, Dellera C, Insaurralde CS, Alejandro RV, Daldin J, Vinzio M, Fernandez RO, Cardonnet LP, Bettini LR, Bisso MC, Osman EM, Setten MG, Lovazzano P, Alvarez J, Villar V, Pozo NC, Grubissich N, Plotnikow GA, Vasquez DN, Ilutovich S, Tiribelli N, Chena A, Pellegrini CA, Saenz MG, Estenssoro E, Brizuela M, Gianinetto H, Gomez PE, Cerrato VI, Bezzi MG, Borello SA, Loiacono FA, Fernandez AM, Knowles S, Reynolds C, Inskip DM, Miller JJ, Kong J, Whitehead C, Bihari S, Seven A, Krstevski A, Rodgers HJ, Millar RT, Mckenna TE, Bailey IM, Hanlon GC, Aneman A, Lynch JM, Azad R, Neal J, Woods PW, Roberts BL, Kol MR, Wong HS, Riss KC, Staudinger T, Wittebole X, Berghe C, Bulpa PA, Dive AM, Verstraete R, Lebbinck H, Vermassen J, Meersseman P, Ceunen H, Rosa JI, Beraldo DO, Piras C, Rampinelli AM, Nassar Jr AP, Mataloun S, Moock M, Thompson MM, Gonçalves CH, Antônio AP, Ascoli A, Biondi RS, Fontenele DC, Nobrega D, Sales VM, Shindhe S, Aiman M, Laffey J, Beloncle F, Davies KG, Cirone R, Manoharan V, Ismail M, Goligher EC, Jassal M, Nishikawa E, Javeed A, Curley G, Rittayamai N, Parotto M, Ferguson ND, Mehta S, Knoll J, Pronovost A, Canestrini S, Bruhn AR, Garcia PH, Aliaga FA, Farías PA, Yumha JS, Ortiz CA, Salas JE, Saez AA, Vega LD, Labarca EF, Martinez FT, Carreño NG, Lora P, Liu H, Liu L, Tang R, Luo X, An Y, Zhao H, Gao Y, Zhai Z, Ye ZL, Wang W, Li W, Li Q, Zheng R, Yu W, Shen J, Li X, Yu T, Wu YQ, Huang XB, He Z, Lu Y, Han H, Zhang F, Sun R, Wang HX, Qin SH, Zhu BH, Zhao J, Liu J, Li B, Liu JL, Zhou FC, Li QJ, Zhang XY, Li-Xin Z, Xin-Hua Q, Jiang L, Gao YN, Zhao XY, Li YY, Li XL, Wang C, Yao Q, Yu R, Chen K, Shao H, Qin B, Huang QQ, Zhu WH, Hang AY, Hua MX, Li Y, Xu Y, Di YD, Ling LL, Qin TH, Wang SH, Qin J, Han Y, Zhou S, Vargas MP, Silesky Jimenez JI, González Rojas MA, Solis-Quesada JE, Ramirez-Alfaro CM, Máca J, Sklienka P, Gjedsted J, Christiansen A, Villamagua BG, Llano M, Burtin P, Buzancais G, Beuret P, Pelletier N, Mortaza S, Mercat A, Chelly J, Jochmans S, Terzi N, Daubin C, Carteaux G, de Prost N, Chiche JD, Daviaud F, Fartoukh M, Barberet G, Biehler J, Dellamonica J, Doyen D, Arnal JM, Briquet A, Hraiech S, Papazian L, Follin A, Roux D, Messika J, Kalaitzis E, Dangers L, Combes A, Au SM, Béduneau G, Carpentier D, Zogheib EH, Dupont H, Ricome S, Santoli FL, Besset SL, Michel P, Gelée B, Danin PE, Goubaux B, Crova PJ, Phan NT, Berkelmans F, Badie JC, Tapponnier R, Gally J, Khebbeb S, Herbrecht JE, Schneider F, Declercq PM, Rigaud JP, Duranteau J, Harrois A, Chabanne R, Marin J, Bigot C, Thibault S, Ghazi M, Boukhazna M, Zein SO, Richecoeur JR, Combaux DM, Grelon F, Le Moal C, Sauvadet EP, Robine A, Lemiale V, Reuter D, Dres M, Demoule A, Goldgran-Toledano D, Baboi L, Guérin C, Lohner R, Kraßler J, Schäfer S, Zacharowski KD, Meybohm P, Reske AW, Simon P, Hopf HF, Schuetz M, Baltus T, Papanikolaou MN, Papavasilopoulou TG, Zacharas GA, Ourailogloy V, Mouloudi EK, Massa EV, Nagy EO, Stamou EE, Kiourtzieva EV, Oikonomou MA, Avila LE, Cortez CA, Citalán JE, Jog SA, Sable SD, Shah B, Gurjar M, Baronia AK, Memon M, Muthuchellappan R, Ramesh VJ, Shenoy A, Unnikrishnan R, Dixit SB, Rhayakar RV, Ramakrishnan N, Bhardwaj VK, Mahto HL, Sagar SV, Palaniswamy V, Ganesan D, Jamaati H, Heidari F, Meaney EA, Nichol A, Knapman KM, O’Croinin D, Dunne ES, Breen DM, Clarkson KP, Jaafar RF, Dwyer R, Amir F, Ajetunmobi OO, O’Muircheartaigh AC, Black CS, Treanor N, Collins DV, Altaf W, Zani G, Fusari M, Spadaro S, Volta CA, Graziani R, Brunettini B, Palmese S, Formenti P, Umbrello M, Lombardo A, Pecci E, Botteri M, Savioli M, Protti A, Mattei A, Schiavoni L, Tinnirello A, Todeschini M, Giarratano A, Cortegiani A, Sher S, Rossi A, Antonelli MM, Montini LM, Casalena P, Scafetti S, Panarello G, Occhipinti G, Patroniti N, Pozzi M, Biscione RR, Poli MM, Raimondi F, Albiero D, Crapelli G, Beck E, Pota V, Schiavone V, Molin A, Tarantino F, Monti G, Frati E, Mirabella L, Cinnella G, Fossali T, Colombo R, Terragni P, Pattarino I, Mojoli F, Braschi A, Borotto EE, Cracchiolo AN, Palma DM, Raponi F, Foti G, Vascotto ER, Coppadoro A, Brazzi L, Floris 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Buise MP, Simonis FD, Schultz MJ, Goodson JC, Browne TS, Navarra L, Hunt A, Hutchison RA, Bailey MB, Newby L, Mcarthur C, Kalkoff M, Mcleod A, Casement J, Hacking DJ, Andersen FH, Dolva MS, Barratt-Due A, Noremark KL, Søreide E, Sjøbø BÅ, Guttormsen AB, Yoshido HL, Aguilar RZ, Oscanoa FM, Alisasis AU, Robles JB, Pasanting-Lim RB, Tan BC, Andruszkiewicz P, Jakubowska K, Coxo CM, Alvarez AM, Oliveira BS, Montanha GM, Barros NC, Pereira CS, Messias AM, Monteiro JM, Araujo AM, Catorze NT, Marum SM, Bouw MJ, Gomes RM, Brito VA, Castro S, Estilita JM, Barros FM, Serra IM, Martinho AM, Tomescu DR, Marcu A, Bedreag OH, Papurica M, Corneci DE, Negoita SI, Grigoriev E, Gritsan AI, Gazenkampf AA, Almekhlafi G, Albarrak MM, Mustafa GM, Maghrabi KA, Salahuddin N, Aisa TM, Al Jabbary AS, Tabhan E, Arabi YM, Trinidad OA, Al Dorzi HM, Tabhan EE, Bolon S, Smith O, Mancebo J, Lopez-Delgado JC, Esteve F, Rialp G, Forteza C, De Haro C, Artigas A, Albaiceta GM, De Cima-Iglesias S, Seoane-Quiroga L, Ruiz-Aguilar AL, Claraco-Vega LM, Soler JA, Lorente MC, Hermosa C, Gordo F, Prieto-González M, López-Messa JB, Perez MP, Perez CP, Allue RM, Roche-Campo F, Ibañez-Santacruz M, Temprano S, Pintado MC, De Pablo R, Gómez PA, Rodriguez Ruiz S, Iglesias Moles S, Jurado MT, Arizmendi A, Piacentini EA, Franco N, Honrubia T, Perez Cheng M, Perez Losada E, Blanco J, Yuste LJ, Carbayo-Gorriz C, Cazorla-Barranquero FG, Alonso JG, Alda RS, Algaba A, Navarro G, Cereijo E, Diaz-Rodriguez E, Pastor Marcos D, Alvarez Montero L, Herrera Para L, Jimenez Sanchez R, Blasco Navalpotro MA, Diaz Abad R, Castro AG, Jose D Artiga M, Ceniceros-Barros A, Montiel González R, Parrilla Toribio D, Penuelas O, Roser TP, Olga MF, Gallego Curto E, Manzano Sánchez R, Imma VP, Elisabet GM, Claverias L, Magret M, Pellicer AM, Rodriguez LL, Sánchez-Ballesteros JS, González-Salamanca A, Jimenez AG, Huerta FP, Sotillo Diaz JJ, Bermejo Lopez E, Llinares Moya DD, Tallet Alfonso AA, Eugenio Luis PS, Sanchez Cesar P, Rafael SI, 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Ramirez-Alfaro CM, Máca J, Sklienka P, Gjedsted J, Christiansen A, Nielsen J, Villamagua BG, Llano M, Burtin P, Buzancais G, Beuret P, Pelletier N, Mortaza S, Mercat A, Chelly J, Jochmans S, Terzi N, Daubin C, Carteaux G, de Prost N, Chiche JD, Daviaud F, Pham T, Fartoukh M, Barberet G, Biehler J, Dellamonica J, Doyen D, Arnal JM, Briquet A, Hraiech S, Papazian L, Follin A, Roux D, Messika J, Kalaitzis E, Dangers L, Combes A, Au SM, Béduneau G, Carpentier D, Zogheib EH, Dupont H, Ricome S, Santoli FL, Besset SL, Michel P, Gelée B, Danin PE, Goubaux B, Crova PJ, Phan NT, Berkelmans F, Badie JC, Tapponnier R, Gally J, Khebbeb S, Herbrecht JE, Schneider F, Declercq PM, Rigaud JP, Duranteau J, Harrois A, Chabanne R, Marin J, Bigot C, Thibault S, Ghazi M, Boukhazna M, Zein SO, Richecoeur JR, Combaux DM, Grelon F, Le Moal C, Sauvadet EP, Robine A, Lemiale V, Reuter D, Dres M, Demoule A, Goldgran-Toledano D, Baboi L, Guérin C, Lohner R, Kraßler J, Schäfer S, Zacharowski KD, Meybohm P, Reske AW, Simon P, Hopf HF, Schuetz M, Baltus T, Papanikolaou MN, Papavasilopoulou TG, Zacharas GA, Ourailogloy V, Mouloudi EK, Massa EV, Nagy EO, Stamou EE, Kiourtzieva EV, Oikonomou MA, Avila LE, Cortez CA, Citalán JE, Jog SA, Sable SD, Shah B, Gurjar M, Baronia AK, Memon M, Muthuchellappan R, Ramesh VJ, Shenoy A, Unnikrishnan R, Dixit SB, Rhayakar RV, Ramakrishnan N, Bhardwaj VK, Mahto HL, Sagar SV, Palaniswamy V, Ganesan D, Hashemian SM, Jamaati H, Heidari F, Meaney EA, Nichol A, Knapman KM, O’Croinin D, Dunne ES, Breen DM, Clarkson KP, Jaafar RF, Dwyer R, Amir F, Ajetunmobi OO, O’Muircheartaigh AC, Black CS, Treanor N, Collins DV, Altaf W, Zani G, Fusari M, Spadaro S, Volta CA, Graziani R, Brunettini B, Palmese S, Formenti P, Umbrello M, Lombardo A, Pecci E, Botteri M, Savioli M, Protti A, Mattei A, Schiavoni L, Tinnirello A, Todeschini M, Giarratano A, Cortegiani A, Sher S, Rossi A, Antonelli MM, Montini LM, Casalena P, Scafetti S, Panarello G, Occhipinti G, Patroniti N, Pozzi M, 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N., Watanabe, E., Yamaji, Y., Shimizu, K., Shiozaki, K., Futami, S., Ryosuke, S., Saito, K., Kameyama, Y., Ueno, K., Izawa, M., Okuda, N., Suzuki, H., Harasawa, T., Nasu, M., Takada, T., Ito, F., Nunomiya, S., Koyama, K., Abe, T., Andoh, K., Kusumoto, K., Hirata, A., Takaba, A., Kimura, H., Matsumoto, S., Higashijima, U., Honda, H., Aoki, N., Imai, H., Ogino, Y., Mizuguchi, I., Ichikado, K., Nitta, K., Mochizuki, K., Hashida, T., Tanaka, H., Nakamura, T., Niimi, D., Ueda, T., Kashiwa, Y., Uchiyama, A., Sabelnikovs, O., Oss, P., Haddad, Y., Liew, K. Y., Namendys-Silva, S. A., Jarquin-Badiola, Y. D., Sanchez-Hurtado, L. A., Gomez-Flores, S. S., Marin, M. C., Villagomez, A. J., Lemus, J. S., Fierro, J. M., Cervantes, M. R., Flores Mejia, F. J., Dector, D., Dector, D. M., Gonzalez, D. R., Estrella, C. R., Sanchez-Medina, J. R., Ramirez-Gutierrez, A., George, F. G., Aguirre, J. S., Buensuseso, J. 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M., Martinho, A. M., Tomescu, D. R., Marcu, A., Bedreag, O. H., Papurica, M., Corneci, D. E., Negoita, S. I., Grigoriev, E., Gritsan, A. I., Gazenkampf, A. A., Almekhlafi, G., Albarrak, M. M., Mustafa, G. M., Maghrabi, K. A., Salahuddin, N., Aisa, T. M., Al Jabbary, A. S., Tabhan, E., Trinidad, O. A., Al Dorzi, H. M., Tabhan, E. E., Bolon, S., Smith, O., Mancebo, J., Lopez-Delgado, J. C., Esteve, F., Rialp, G., Forteza, C., De Haro, C., Artigas, A., Albaiceta, G. M., De Cima-Iglesias, S., Seoane-Quiroga, L., Ruiz-Aguilar, A. L., Claraco-Vega, L. M., Soler, J. A., Lorente, M. C., Hermosa, C., Gordo, F., Prieto-Gonzalez, M., Lopez-Messa, J. B., Perez, M. P., Perez, C. P., Allue, R. M., Roche-Campo, F., Ibanez-Santacruz, M., Temprano, S., Pintado, M. C., De Pablo, R., Gomez, P. A., Rodriguez Ruiz, S., Iglesias Moles, S., Jurado, M. T., Arizmendi, A., Piacentini, E. A., Franco, N., Honrubia, T., Perez Cheng, M., Perez Losada, E., Blanco, J., Yuste, L. J., Carbayo-Gorriz, C., Cazorla-Barranquero, F. G., Alonso, J. G., Alda, R. S., Algaba, A., Navarro, G., Cereijo, E., Diaz-Rodriguez, E., Pastor Marcos, D., Alvarez Montero, L., Herrera Para, L., Jimenez Sanchez, R., Blasco Navalpotro, M. A., Diaz Abad, R., Castro, A. G., Jose D Artiga, M., Ceniceros-Barros, A., Montiel Gonzalez, R., Parrilla Toribio, D., Penuelas, O., Roser, T. P., Olga, M. F., Gallego Curto, E., Manzano Sanchez, R., Imma, V. P., Elisabet, G. M., Claverias, L., Magret, M., Pellicer, A. M., Rodriguez, L. L., Sanchez-Ballesteros, J. S., Gonzalez-Salamanca, A., Jimenez, A. G., Huerta, F. P., Sotillo Diaz, J. J., Bermejo Lopez, E., Llinares Moya, D. D., Tallet Alfonso, A. A., Eugenio Luis, P. S., Sanchez Cesar, P., Rafael, S. I., Virgilio, C. G., Recio, N. N., Adamsson, R. O., Rylander, C. C., Holzgraefe, B., Broman, L. M., Wessbergh, J., Persson, L., Schioler, F., Kedelv, H., Oscarsson Tibblin, A., Appelberg, H., Hedlund, L., Helleberg, J., Eriksson, K. E., Glietsch, R., Larsson, N., Nygren, I., Nunes, S. L., Morin, A. K., Kander, T., Adolfsson, A., Zender, H. O., Leemann-Refondini, C., Elatrous, S., Bouchoucha, S., Chouchene, I., Ouanes, I., Souissi, A. B., Kamoun, S., Demirkiran, O., Aker, M., Erbabacan, E., Ceylan, I., Girgin, N. K., Ozcelik, M., Unal, N., Meco, B. C., Akyol, O. O., Derman, S. S., Kennedy, B., Parhar, K., Srinivasa, L., Hopkins, P., Mellis, C., Kakar, V., Hadfield, D., Vercueil, A., Bhowmick, K., Humphreys, S. K., Ferguson, A., Mckee, R., Raj, A. S., Fawkes, D. A., Watt, P., Twohey, L., Jha, R. R., Thomas, M., Morton, A., Kadaba, V., Smith, M. J., Hormis, A. P., Kannan, S. G., Namih, M., Reschreiter, H., Camsooksai, J., Kumar, A., Rugonfalvi, S., Nutt, C., Oneill, O., Seasman, C., Dempsey, G., Scott, C. J., Ellis, H. E., Mckechnie, S., Hutton, P. J., Di Tomasso, N. N., Vitale, M. N., Griffin, R. O., Dean, M. N., Cranshaw, J. H., Willett, E. 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Subjects
Male, ARDS, procedure, blood oxygen tension, Critical Care and Intensive Care Medicine, Severity of Illness Index, law.invention, 0302 clinical medicine, law, Hospital Mortality, Respiratory Distress Syndrome, Acute respiratory distress syndrome, adult respiratory distress syndrome, Middle Aged, Intensive care unit, Intensive Care Units, medicine.anatomical_structure, Treatment Outcome, priority journal, positive end expiratory pressure, Noninvasive ventilation, disease severity, Female, treatment outcome, Aged, prospective study, Human, Adult, Pulmonary and Respiratory Medicine, medicine.medical_specialty, cohort analysi, Intensive Care Unit, disease classification, Acute respiratory distress, Article, NO, 03 medical and health sciences, acute respiratory distress syndrome, noninvasive ventilation, length of stay, Severity of illness, Settore MED/41 - ANESTESIOLOGIA, medicine, Sequential Organ Failure Assessment Score, Humans, In patient, Aged, Respiratory Distress Syndrome, Adult, Noninvasive Ventilation, Intensive care medicine, outcome assessment, Lung, business.industry, 030208 emergency & critical care medicine, medicine.disease, major clinical study, mortality, respiratory tract diseases, breathing rate, multicenter study, 030228 respiratory system, incidence, Observational study, observational study, business
Abstract

Rationale: Noninvasive ventilation (NIV) is increasingly used in patients with acute respiratory distress syndrome (ARDS). The evidence supporting NIV use in patients with ARDS remains relatively sparse.Objectives: To determine whether, during NIV, the categorization of ARDS severity based on the PaO2/FiO2 Berlin criteria is useful.Methods: The LUNG SAFE (Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure) study described the management of patients with ARDS. This substudy examines the current practice of NIV use in ARDS, the utility of the PaO2/FiO2 ratio in classifying patients receiving NIV, and the impact of NIV on outcome.Measurements and Main Results: Of 2,813 patients with ARDS, 436 (15.5%) were managed with NIV on Days 1 and 2 following fulfillment of diagnostic criteria. Classification of ARDS severity based on PaO2/FiO2 ratio was associated with an increase in intensity of ventilatory support, NIV failure, and intensive care unit (ICU) mortality. NIV failure occurred in 22.2% of mild, 42.3% of moderate, and 47.1% of patients with severe ARDS. Hospital mortality in patients with NIV success and failure was 16.1% and 45.4%, respectively. NIV use was independently associated with increased ICU (hazard ratio, 1.446 [95% confidence interval, 1.159–1.805]), but not hospital, mortality. In a propensity matched analysis, ICU mortality was higher in NIV than invasively ventilated patients with a PaO2/FiO2 lower than 150 mm Hg.Conclusions: NIV was used in 15% of patients with ARDS, irrespective of severity category. NIV seems to be associated with higher ICU mortality in patients with a PaO2/FiO2 lower than 150 mm Hg.

Published
2017

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