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1. Simvastatin in Critically Ill Patients with Covid-19.

Author

Hills TE, Lorenzi E, Berry LR, Shyamsundar M, Al-Beidh F, Annane D, Arabi Y, Aryal D, Au C, Beane A, Bhimani Z, Bonten M, Bradbury CA, Brunkhorst FM, Burrell A, Buxton M, Calfee CS, Cecconi M, Cheng AC, Cove ME, Detry MA, Estcourt LJ, Fitzgerald M, Goligher EC, Goossens H, Green C, Haniffa R, Harrison DA, Hashmi M, Higgins AM, Horvat C, Huang DT, Ichihara N, Jayakumar D, Kruger PS, Lamontagne F, Lampro L, Lawler PR, Marshall JC, Mason AJ, McGlothlin A, McGuinness S, McQuilten ZK, McVerry BJ, Mouncey PR, Murthy S, Neal MD, Nichol AD, O'Kane CM, Parke RL, Parker JC, Rabindrarajan E, Reyes LF, Rowan KM, Saito H, Santos M, Saunders CT, Seymour CW, Shankar-Hari M, Sinha P, Thompson BT, Turgeon AF, Turner AM, van de Veerdonk F, Weis S, Young IS, Zarychanski R, Lewis RJ, McArthur CJ, Angus DC, Berry SM, Derde LPG, Webb SA, Gordon AC, and McAuley DF

Subjects
Humans, Bayes Theorem, COVID-19 Drug Treatment, Hospital Mortality, Treatment Outcome, COVID-19 mortality, COVID-19 therapy, Critical Illness mortality, Critical Illness therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Simvastatin therapeutic use
Abstract

Background: The efficacy of simvastatin in critically ill patients with coronavirus disease 2019 (Covid-19) is unclear., Methods: In an ongoing international, multifactorial, adaptive platform, randomized, controlled trial, we evaluated simvastatin (80 mg daily) as compared with no statin (control) in critically ill patients with Covid-19 who were not receiving statins at baseline. The primary outcome was respiratory and cardiovascular organ support-free days, assessed on an ordinal scale combining in-hospital death (assigned a value of -1) and days free of organ support through day 21 in survivors; the analyis used a Bayesian hierarchical ordinal model. The adaptive design included prespecified statistical stopping criteria for superiority (>99% posterior probability that the odds ratio was >1) and futility (>95% posterior probability that the odds ratio was <1.2)., Results: Enrollment began on October 28, 2020. On January 8, 2023, enrollment was closed on the basis of a low anticipated likelihood that prespecified stopping criteria would be met as Covid-19 cases decreased. The final analysis included 2684 critically ill patients. The median number of organ support-free days was 11 (interquartile range, -1 to 17) in the simvastatin group and 7 (interquartile range, -1 to 16) in the control group; the posterior median adjusted odds ratio was 1.15 (95% credible interval, 0.98 to 1.34) for simvastatin as compared with control, yielding a 95.9% posterior probability of superiority. At 90 days, the hazard ratio for survival was 1.12 (95% credible interval, 0.95 to 1.32), yielding a 91.9% posterior probability of superiority of simvastatin. The results of secondary analyses were consistent with those of the primary analysis. Serious adverse events, such as elevated levels of liver enzymes and creatine kinase, were reported more frequently with simvastatin than with control., Conclusions: Although recruitment was stopped because cases had decreased, among critically ill patients with Covid-19, simvastatin did not meet the prespecified criteria for superiority to control. (REMAP-CAP ClinicalTrials.gov number, NCT02735707.)., (Copyright © 2023 Massachusetts Medical Society.)

Published
2023
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2. A Bayesian reanalysis of the Standard versus Accelerated Initiation of Renal-Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial.

Author

Zampieri FG, da Costa BR, Vaara ST, Lamontagne F, Rochwerg B, Nichol AD, McGuinness S, McAuley DF, Ostermann M, Wald R, and Bagshaw SM

Subjects
Bayes Theorem, Humans, Probability, Renal Replacement Therapy methods, Acute Kidney Injury therapy, Critical Illness therapy
Abstract

Background: Timing of initiation of kidney-replacement therapy (KRT) in critically ill patients remains controversial. The Standard versus Accelerated Initiation of Renal-Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial compared two strategies of KRT initiation (accelerated versus standard) in critically ill patients with acute kidney injury and found neutral results for 90-day all-cause mortality. Probabilistic exploration of the trial endpoints may enable greater understanding of the trial findings. We aimed to perform a reanalysis using a Bayesian framework., Methods: We performed a secondary analysis of all 2927 patients randomized in multi-national STARRT-AKI trial, performed at 168 centers in 15 countries. The primary endpoint, 90-day all-cause mortality, was evaluated using hierarchical Bayesian logistic regression. A spectrum of priors includes optimistic, neutral, and pessimistic priors, along with priors informed from earlier clinical trials. Secondary endpoints (KRT-free days and hospital-free days) were assessed using zero-one inflated beta regression., Results: The posterior probability of benefit comparing an accelerated versus a standard KRT initiation strategy for the primary endpoint suggested no important difference, regardless of the prior used (absolute difference of 0.13% [95% credible interval [CrI] - 3.30%; 3.40%], - 0.39% [95% CrI - 3.46%; 3.00%], and 0.64% [95% CrI - 2.53%; 3.88%] for neutral, optimistic, and pessimistic priors, respectively). There was a very low probability that the effect size was equal or larger than a consensus-defined minimal clinically important difference. Patients allocated to the accelerated strategy had a lower number of KRT-free days (median absolute difference of - 3.55 days [95% CrI - 6.38; - 0.48]), with a probability that the accelerated strategy was associated with more KRT-free days of 0.008. Hospital-free days were similar between strategies, with the accelerated strategy having a median absolute difference of 0.48 more hospital-free days (95% CrI - 1.87; 2.72) compared with the standard strategy and the probability that the accelerated strategy had more hospital-free days was 0.66., Conclusions: In a Bayesian reanalysis of the STARRT-AKI trial, we found very low probability that an accelerated strategy has clinically important benefits compared with the standard strategy. Patients receiving the accelerated strategy probably have fewer days alive and KRT-free. These findings do not support the adoption of an accelerated strategy of KRT initiation., (© 2022. The Author(s).)

Published
2022
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3. Reduced exposure to vasopressors through permissive hypotension to reduce mortality in critically ill people aged 65 and over: the 65 RCT.

Author

Mouncey PR, Richards-Belle A, Thomas K, Harrison DA, Sadique MZ, Grieve RD, Camsooksai J, Darnell R, Gordon AC, Henry D, Hudson N, Mason AJ, Saull M, Whitman C, Young JD, Lamontagne F, and Rowan KM

Subjects
Adult, Aged, Cost-Benefit Analysis, Humans, Quality of Life, Quality-Adjusted Life Years, Randomized Controlled Trials as Topic, Critical Illness, Hypotension drug therapy
Abstract

Background: Vasopressors are administered to critical care patients to avoid hypotension, which is associated with myocardial injury, kidney injury and death. However, they work by causing vasoconstriction, which may reduce blood flow and cause other adverse effects. A mean arterial pressure target typically guides administration. An individual patient data meta-analysis (Lamontagne F, Day AG, Meade MO, Cook DJ, Guyatt GH, Hylands M, et al. Pooled analysis of higher versus lower blood pressure targets for vasopressor therapy septic and vasodilatory shock. Intensive Care Med 2018; 44 :12-21) suggested that greater exposure, through higher mean arterial pressure targets, may increase risk of death in older patients., Objective: To estimate the clinical effectiveness and cost-effectiveness of reduced vasopressor exposure through permissive hypotension (i.e. a lower mean arterial pressure target of 60-65 mmHg) in older critically ill patients., Design: A pragmatic, randomised clinical trial with integrated economic evaluation., Setting: Sixty-five NHS adult general critical care units., Participants: Critically ill patients aged ≥ 65 years receiving vasopressors for vasodilatory hypotension., Interventions: Intervention - permissive hypotension (i.e. a mean arterial pressure target of 60-65 mmHg). Control (usual care) - a mean arterial pressure target at the treating clinician's discretion., Main Outcome Measures: The primary clinical outcome was 90-day all-cause mortality. The primary cost-effectiveness outcome was 90-day incremental net monetary benefit. Secondary outcomes included receipt and duration of advanced respiratory and renal support, mortality at critical care and acute hospital discharge, and questionnaire assessment of cognitive decline and health-related quality of life at 90 days and 1 year., Results: Of 2600 patients randomised, 2463 (permissive hypotension, n  = 1221; usual care, n  = 1242) were analysed for the primary clinical outcome. Permissive hypotension resulted in lower exposure to vasopressors than usual care [mean duration 46.0 vs. 55.9 hours, difference -9.9 hours (95% confidence interval -14.3 to -5.5 hours); total noradrenaline-equivalent dose 31.5 mg vs. 44.3 mg, difference -12.8 mg (95% CI -18.0 mg to -17.6 mg)]. By 90 days, 500 (41.0%) patients in the permissive hypotension group and 544 (43.8%) patients in the usual-care group had died (absolute risk difference -2.85%, 95% confidence interval -6.75% to 1.05%; p  = 0.154). Adjustment for prespecified baseline variables resulted in an odds ratio for 90-day mortality of 0.82 (95% confidence interval 0.68 to 0.98) favouring permissive hypotension. There were no significant differences in prespecified secondary outcomes or subgroups; however, patients with chronic hypertension showed a mortality difference favourable to permissive hypotension. At 90 days, permissive hypotension showed similar costs to usual care. However, with higher incremental life-years and quality-adjusted life-years in the permissive hypotension group, the incremental net monetary benefit was positive, but with high statistical uncertainty (£378, 95% confidence interval -£1347 to £2103)., Limitations: The intervention was unblinded, with risk of bias minimised through central allocation concealment and a primary outcome not subject to observer bias. The control group event rate was higher than anticipated., Conclusions: In critically ill patients aged ≥ 65 years receiving vasopressors for vasodilatory hypotension, permissive hypotension did not significantly reduce 90-day mortality compared with usual care. The absolute treatment effect on 90-day mortality, based on 95% confidence intervals, was between a 6.8-percentage reduction and a 1.1-percentage increase in mortality., Future Work: Future work should (1) update the individual patient data meta-analysis, (2) explore approaches for evaluating heterogeneity of treatment effect and (3) explore 65 trial conduct, including use of deferred consent, to inform future trials., Trial Registration: Current Controlled Trials ISRCTN10580502., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 14. See the NIHR Journals Library website for further project information.

Published
2021
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4. Canadian Critical Care Society clinical practice guideline: The use of vasopressin and vasopressin analogues in critically ill adults with distributive shock.

Author

Honarmand K, Um KJ, Belley-Côté EP, Alhazzani W, Farley C, Fernando SM, Fiest K, Grey D, Hajdini E, Herridge M, Hrymak C, Møller MH, Kanji S, Lamontagne F, Lauzier F, Mehta S, Paunovic B, Singal R, Tsang JL, Wynne C, and Rochwerg B

Subjects
Adult, Canada, Critical Care, Humans, Critical Illness, Shock drug therapy, Vasopressins therapeutic use
Abstract

Purpose: Hemodynamic management of adults with distributive shock often includes the use of catecholamine-based vasoconstricting medications. It is unclear whether adding vasopressin or vasopressin analogues to catecholamine therapy is beneficial in the management of patients with distributive shock. The purpose of this guideline was to develop an evidence-based recommendation regarding the addition of vasopressin to catecholamine vasopressors in the management of adults with distributive shock., Methods: We summarized the evidence informing this recommendation by updating a recently published meta-analysis. Then, a multidisciplinary panel from the Canadian Critical Care Society developed the recommendation using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology., Results: The updated systematic review identified 25 randomized controlled trials including a total of 3,737 patients with distributive shock. Compared with catecholamine therapy alone, the addition of vasopressin or its analogues was associated with a reduced risk of mortality (relative risk [RR], 0.91; 95% confidence interval [CI], 0.85 to 0.99; low certainty), reduced risk of atrial fibrillation (RR, 0.77; 95% CI, 0.67 to 0.88; high certainty), and increased risk of digital ischemia (RR, 2.56; 95% CI, 1.24 to 5.25; moderate certainty)., Conclusions: After considering certainty in the evidence, values and preferences, cost, and other factors, the expert guideline panel suggests using vasopressin or vasopressin analogues in addition to catecholamines over catecholamine vasopressors alone for the management of distributive shock (conditional recommendation, low certainty evidence).

Published
2020
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5. Vitamin C for the critically ill: Is the evidence strong enough?

Author

L Langlois P and Lamontagne F

Subjects
Administration, Intravenous, Ascorbic Acid Deficiency etiology, Humans, Severity of Illness Index, Treatment Outcome, Ascorbic Acid administration & dosage, Ascorbic Acid Deficiency therapy, Critical Illness therapy, Dietary Supplements, Vitamins administration & dosage
Abstract

Vitamin C exhibits interesting properties in the context of critical illness, with benefits described in neurologic, cardiovascular, renal, and hematologic systems, both in in vitro and in animal models. Through direct effects on bacterial replication, immunomodulation, and antioxidant reserve of the organism, vitamin C directly affects the pathophysiological process of sepsis, trauma, burn, and systemic inflammation. Even if several observational trials have linked vitamin C deficiency to worse outcomes, the evidence is not such as to provide us with a distinction between causality effects or simple epiphenomenon, and the current focus is on interventional trials. Pharmacokinetic data suggest that a minimal supplementation of 3 g/d intravenously is required to restore normal serum values in critically ill patients with known deficiency. According to these data, only five trials, including a retrospective analysis, studied pharmacologic dose: three as an antioxidant cocktail and two as monotherapy. The largest trial, conducted in 2002, reported reduced incidence of multiorgan failure and duration of mechanical ventilation. Recently a retrospective analysis reported impressive results after administration of vitamin C, thiamine, and hydrocortisone. The two most recent trials reported improved clinical outcomes, including improved mortality, but contained significant methodological limitations. A recent systematic review did not find clinical benefits with the most-studied low-dose oral supplementation, potentially because of suboptimal or insufficient repletion. Current guidelines do not support the administration of high-dose vitamin C in critically ill patients. Future larger trials are required to support any therapy, but the low cost and safety profile can justify supplementation in the meantime. Metabolomics study will further help understand biological effect., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Published
2019
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6. Early Evidence of Sepsis-Associated Hyperperfusion-A Study of Cerebral Blood Flow Measured With MRI Arterial Spin Labeling in Critically Ill Septic Patients and Control Subjects.

Author

Masse MH, Richard MA, D'Aragon F, St-Arnaud C, Mayette M, Adhikari NKJ, Fraser W, Carpentier A, Palanchuck S, Gauthier D, Lanthier L, Touchette M, Lamontagne A, Chénard J, Mehta S, Sansoucy Y, Croteau E, Lepage M, and Lamontagne F

Subjects
Adult, Aged, Blood Pressure, Brain diagnostic imaging, Brain metabolism, Brain pathology, Case-Control Studies, Cross-Over Studies, Deep Sedation adverse effects, Female, Humans, Hypertension complications, Hypertension physiopathology, Magnetic Resonance Imaging, Male, Middle Aged, Neuroimaging, Oxygen Consumption, Respiration, Artificial adverse effects, Sepsis complications, Sepsis diagnostic imaging, Sepsis pathology, Spin Labels, Young Adult, Brain blood supply, Cerebrovascular Circulation, Critical Illness, Sepsis physiopathology
Abstract

Objectives: Mechanisms underlying sepsis-associated encephalopathy remain unclear, but reduced cerebral blood flow, alone or in conjunction with altered autoregulation, is reported as a potential contributor. We compared cerebral blood flow of control subjects and vasopressor-dependent septic patients., Design: Randomized crossover study., Setting: MRI with arterial spin labeling., Patients: Ten sedated septic patients on mechanical ventilation (four with controlled chronic hypertension) and 12 control subjects (six with controlled chronic hypertension) were enrolled. Mean ± SD ages were 61.4 ± 10.2 and 44.2 ± 12.8 years, respectively (p = 0.003). Mean Acute Physiology and Chronic Health Evaluation II score of septic patients at ICU admission was 27.7 ± 6.6., Interventions: To assess the potential confounding effects of sedation and mean arterial pressure, we measured cerebral blood flow with and without sedation with propofol in control subjects and at a target mean arterial pressure of 65 mm Hg and greater than or equal to 75 mm Hg in septic patients. The sequence of sedation versus no sedation and mean arterial pressure targets were randomized., Measurements and Main Results: In septic patients, cerebral blood flow measured at a mean arterial pressure target of 65 mm Hg (40.4 ± 10.9 mL/100 g/min) was not different from cerebral blood flow measured at a mean arterial pressure target of greater than or equal to 75 mm Hg (41.3 ± 9.8 mL/100 g/min; p = 0.65). In control subjects, we observed no difference in cerebral blood flow measured without and with sedation (24.8 ± 4.2 vs 24.9 ± 5.9 mL/100 g/min; p = 0.93). We found no interaction between chronic hypertension and the effect of sedation or mean arterial pressure targets. Cerebral blood flow measured in sedated septic patients (mean arterial pressure target 65 mm Hg) was 62% higher than in sedated control subjects (p = 0.001)., Conclusions: In septic patients, cerebral blood flow was higher than in sedated control subjects and did not vary with mean arterial pressure targets. Further research is required to understand the clinical significance of cerebral hyperperfusion in septic patients on vasopressors and to reassess the neurologic effects of current mean arterial pressure targets in sepsis.

Published
2018
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7. A systematic review of vasopressor blood pressure targets in critically ill adults with hypotension.

Author

Hylands M, Moller MH, Asfar P, Toma A, Frenette AJ, Beaudoin N, Belley-Côté É, D'Aragon F, Laake JH, Siemieniuk RA, Charbonney E, Lauzier F, Kwong J, Rochwerg B, Vandvik PO, Guyatt G, and Lamontagne F

Subjects
Adult, Arterial Pressure drug effects, Blood Pressure drug effects, Humans, Randomized Controlled Trials as Topic, Vasoconstrictor Agents adverse effects, Critical Illness, Hypotension drug therapy, Vasoconstrictor Agents therapeutic use
Abstract

Purpose: Clinicians must balance the risks from hypotension with the potential adverse effects of vasopressors. Experts have recommended a mean arterial pressure (MAP) target of at least 65 mmHg, and higher in older patients and in patients with chronic hypertension or atherosclerosis. We conducted a systematic review of randomized-controlled trials comparing higher vs lower blood pressure targets for vasopressor therapy administered to hypotensive critically ill patients., Methods: We searched MEDLINE®, EMBASE™, and the Cochrane Central Register of Controlled Trials for studies of higher vs lower blood pressure targets for vasopressor therapy in critically ill hypotensive adult patients. Two reviewers independently assessed trial eligibility based on titles and abstracts, and they then selected full-text reports. Outcomes, subgroups, and analyses were prespecified. We used GRADE (Grading of Recommendations Assessment, Development and Evaluation) to rate the overall confidence in the estimates of intervention effects., Results: Of 8001 citations, we retrieved 57 full-text articles and ultimately included two randomized-controlled trials (894 patients). Higher blood pressure targets were not associated with lower mortality (relative risk [RR], 1.05; 95% confidence interval [CI], 0.90 to 1.23; P = 0.54), and neither age (P = 0.17) nor chronic hypertension (P = 0.32) modified the overall effect. Nevertheless, higher blood pressure targets were associated with a greater risk of new-onset supraventricular cardiac arrhythmia (RR, 2.08; 95% CI, 1.28 to 3.38; P < 0.01)., Conclusion: Current evidence does not support a MAP target > 70 mmHg in hypotensive critically ill adult patients requiring vasopressor therapy.

Published
2017
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8. Corticosteroid therapy in critical illness due to seasonal and pandemic influenza.

Author

Yale P, Adhikari NK, Masse V, Fowler RA, Xiong W, McGeer A, Cann D, Rudnick W, Green K, Meade MO, Valiquette L, and Lamontagne F

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Canada epidemiology, Critical Illness epidemiology, Female, Humans, Influenza A Virus, H1N1 Subtype, Influenza, Human diagnosis, Influenza, Human epidemiology, Logistic Models, Male, Middle Aged, Multivariate Analysis, Retrospective Studies, Seasons, Adrenal Cortex Hormones therapeutic use, Anti-Inflammatory Agents therapeutic use, Critical Illness therapy, Disease Outbreaks, Influenza, Human drug therapy, Pandemics, Practice Patterns, Physicians' statistics & numerical data
Abstract

Background: Survey data suggest that Canadian intensivists administer corticosteroids to critically ill patients primarily in response to airway obstruction, perceived risk for adrenal insufficiency and hemodynamic instability., Objective: To describe variables independently associated with systemic corticosteroid therapy during an influenza outbreak., Methods: The present analysis was retrospective cohort study involving critically ill patients with influenza in two Canadian cities. Hospital records were reviewed for critically ill patients treated in the intensive care units (ICUs) of eight hospitals in Canada during the 2008 to 2009 and 2009 to 2010 influenza outbreaks. Abstracted data included demographic information, symptoms at disease onset, chronic comorbidities and baseline illness severity scores. Corticosteroid use data were extracted for every ICU day and expressed as hydrocortisone dose equivalent in mg. Multivariable regression models were constructed to identify variables independently associated with corticosteroid therapy in the ICU., Results: The study cohort included 90 patients with a mean (± SD) age of 55.0 ± 17.3 years and Acute Physiology and Chronic Health Evaluation II score of 19.8 ± 8.3. Patients in 2009 to 2010 were younger with more severe lung injury but similar exposure to corticosteroids. Overall, 54% of patients received corticosteroids at a mean daily dose of 343 ± 330 mg of hydrocortisone for 8.5 ± 4.8 days. Variables independently associated with corticosteroid therapy in the ICU were history of airway obstruction (OR 4.8 [95% CI 1.6 to 14.9]) and hemodynamic instability (OR 4.6 [95% CI 1.2 to 17.8])., Conclusion: Observational data revealed that hemodynamic instability and airway obstruction were associated with corticosteroid therapy in the critical care setting, similar to a recent survey of stated practice. Efforts to determine the effects of corticosteroids in the ICU for these specific clinical situations are warranted.

Published
2015
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9. Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic

Author

Reid, Julie C., Molloy, Alex, Strong, Geoff, Kelly, Laurel, O’Grady, Heather, Cook, Deborah, Archambault, Patrick M., Ball, Ian, Berney, Sue, Burns, Karen E. A., D’Aragon, Frederick, Duan, Erick, English, Shane W., Lamontagne, François, Pastva, Amy M., Rochwerg, Bram, Seely, Andrew J. E., Serri, Karim, Tsang, Jennifer L. Y., Verceles, Avelino C., Reeve, Brenda, Fox-Robichaud, Alison, Muscedere, John, Herridge, Margaret, Thabane, Lehana, and Kho, Michelle E.

Published
2022
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10. A Bayesian reanalysis of the standard versus accelerated initiation of renal-replacement therapy in acute kidney injury (STARRT-AKI) trial

Author

Zampieri, Fernando G., da Costa, Bruno R., Vaara, Suvi T., Lamontagne, François, Rochwerg, Bram, Nichol, Alistair D., McGuinness, Shay, McAuley, Danny F., Ostermann, Marlies, Wald, Ron, Bagshaw, Sean M., Adhikari, Neill K. J., Bellomo, Rinaldo, Dreyfuss, Didier, Du, Bin, Gallagher, Martin P., Gaudry, Stéphane, Joannidis, Michael, Liu, Kathleen D., McAuley, Daniel F., McGuinness, Shay P., Palevsky, Paul M., Qiu, Haibo, Pettilä, Ville, Schneider, Antoine G., Smith, Orla M., Vaara, Suvi, Weir, Matthew, Eastwood, Glenn M., Peck, Leah, Young, Helen, Kruger, Peter, Laurie, Gordon, Saylor, Emma, Meyer, Jason, Venz, Ellen, Wetzig, Krista, French, Craig, McGain, Forbes, Mulder, John, Fennessy, Gerard, Koottayi, Sathyajith, Bates, Samantha, Towns, Miriam, Morgan, Rebecca, Tippett, Anna, Udy, Andrew, Mason, Chris, Licari, Elisa, Gantner, Dashiell, McClure, Jason, Nichol, Alistair, McCracken, Phoebe, Board, Jasmin, Martin, Emma, Vallance, Shirley, Young, Meredith, Vladic, Chelsey, McGloughlin, Steve, Gattas, David, Buhr, Heidi, Coles, Jennifer, Hutch, Debra, Wun, James, Cole, Louise, Whitehead, Christina, Lowrey, Julie, Masters, Kristy, Gresham, Rebecca, Campbell, Victoria, Gutierrez, David, Brailsford, Jane, Forbes, Loretta, Murray, Lauren, Maguire, Teena, NiChonghaile, Martina, Orford, Neil, Bone, Allison, Elderkin, Tania, Salerno, Tania, Chimunda, Tim, Fletcher, Jason, Broadfield, Emma, Porwal, Sanjay, Knott, Cameron, Boschert, Catherine, Smith, Julie, Richardson, Angus, Hill, Dianne, Duke, Graeme, Oziemski, Peter, Cegarra, Santiago, Chan, Peter, Welsh, Deborah, Hunter, Stephanie, Roodenburg, Owen, Dyett, John, Kokotsis, Nicos, Moser, Max, Yang, Yang, Padayachee, Laven, Vetro, Joseph, Gangopadhyay, Himangsu, Kaufman, Melissa, Ghosh, Angaj, Said, Simone, Patel, Alpesh, Bihari, Shailesh, Matheson, Elisha, Jin, Xia, Shrestha, Tapaswi, Schwartz, Kate, Cross, Rosalba, Cheung, Winston, Wong, Helen, Kol, Mark, Shah, Asim, Wang, Amanda Y., Endre, Zoltan, Bradford, Celia, Janin, Pierre, Finfer, Simon, Diel, Naomi, Gatward, Jonathan, Hammond, Naomi, Delaney, Anthony, Bass, Frances, Yarad, Elizabeth, Buscher, Hergen, Reynolds, Claire, Baker, Nerilee, Bellmann, Romuald, Peer, Andreas, Hasslacher, Julia, Koglberger, Paul, Klein, Sebastian, Zotter, Klemens, Brandtner, Anna, Finkenstedt, Armin, Ditlbacher, Adelheid, Hartig, Frank, Fries, Dietmar, Bachler, Mirjam, Schenk, Bettina, Wagner, Martin, Eller, Philipp, Staudinger, Thomas, Tiller, Esther, Schellongowski, Peter, Bojic, Andja, Hoste, Eric, Bracke, Stephanie, De Crop, Luc, Vermeiren, Daisy, Thome, Fernando, Chiella, Bianca, Fendt, Lucia, Antunes, Veronica, Lafrance, Jean-Philippe, D’Aragon, Frédérick, St-Arnaud, Charles, Mayette, Michael, Carbonnaeu, Élaine, Marchand, Joannie, Masse, Marie-Hélène, Ladouceur, Marilène, Turgeon, Alexis F., Lauzier, François, Bellemare, David, Francoeur, Charles Langis, LeBlanc, Guillaume, Guilbault, Gabrielle, Grenier, Stéphanie, Cloutier, Eve, Boivin, Annick, Delisle-Thibault, Charles, Giannakouros, Panagiota, Costerousse, Olivier, Cailhier, Jean-François, Carrier, François-Martin, Ghamraoui, Ali, Lebrasseur, Martine, Benettaib, Fatna, Salamé, Maya, Boumahni, Dounia, Sia, Ying Tung, Naud, Jean-François, Roy, Isabelle, Stelfox, Henry T., Ruddell, Stacey, Manns, Braden J., Duggan, Shelley, Carney, Dominic, Barchard, Jennifer, Whitlock, Richard P., Belley-Cote, Emilie, Savija, Nevena, Sabev, Alexandra, Campbell, Troy, Creary, Thais, Devereaux, Kelson, Brodutch, Shira, Rigatto, Claudio, Paunovic, Bojan, Mooney, Owen, Glybina, Anna, Harasemiw, Oksana, Di Nella, Michelle, Harmon, John, Mehta, Navdeep, Lakatos, Louis, Haslam, Nicole, Lellouche, Francois, Simon, Mathieu, Tung, Ying, Lizotte, Patricia, Bourchard, Pierre-Alexandre, Karachi, Tim, Millen, Tina, Muscedere, John, Maslove, David, Gordon Boyd, J., Sibley, Stephanie, Drover, John, Hunt, Miranda, Georgescu, Ilinca, Wax, Randy, Lenga, Ilan, Sridhar, Kavita, Steele, Andrew, Fusco, Kelly, Ghate, Taneera, Tolibas, Michael, Robinson, Holly, Weir, Matthew A., Taneja, Ravi, Ball, Ian M., Garg, Amit, Campbell, Eileen, Ovsenek, Athena, van Diepen, Sean, Baig, Nadia, Magder, Sheldon, Yao, Han, Alam, Ahsan, Campisi, Josie, MacIntyre, Erika, Rokosh, Ella, Scherr, Kimberly, Lapinsky, Stephen, Mehta, Sangeeta, Shah, Sumesh, Niven, Daniel J., Russell, Michael, Jim, Kym, Brown, Gillian, Oxtoby, Kerry, Hall, Adam, Benoit, Luc, Sokolowski, Colleen, Prasad, Bhanu, Rao, Jag, Giebel, Shelley, Kutsogiannis, Demetrios J., Thompson, Patricia, Thompson, Tayne, Cirone, Robert, Kavikondala, Kanthi, Soth, Mark, Clarke, France, Takaoka, Alyson, Mazer, David, Burns, Karen, Friedrich, Jan, Klein, David, Sandhu, Gyan, Santos, Marlene, Khalid, Imrana, Hodder, Jennifer, Dodek, Peter, Ayas, Najib, Alcuaz, Victoria, Suen, Gabriel, Rewa, Oleksa, Singh, Gurmeet, Norris, Sean, Gibson, Neil, Arias, Castro, Shami, Aysha, Pelletier, Celine, Zahirieh, Alireza, Amaral, Andre, Marinoff, Nicole, Kaur, Navjot, Perez, Adic, Wang, Jane, Haljan, Gregory, Condin, Christopher, McIntyre, Lauralyn, Gomes, Brigette, Porteous, Rebecca, Watpool, Irene, Hiremath, Swapnil, Clark, Edward, Herridge, Margaret S., Backhouse, Felicity, Elizabeth Wilcox, M., Walczak, Karolina, Ki, Vincent, Sharman, Asheer, Romano, Martin, Noel Gibney, R. T., Romanovsky, Adam S., McCoshen, Lorena, Wood, Gordon, Ovakim, Daniel, Auld, Fiona, Carney, Gayle, Duan, Meili, Ji, Xiaojun, Guo, Dongchen, Qi, Zhili, Lin, Jin, Zhang, Meng, Dong, Lei, Liu, Jingfeng, Liu, Pei, Zhi, Deyuan, Bai, Guoqiang, Qiu, Yu, Yang, Ziqi, Bai, Jing, Liu, Zhuang, Zhuang, Haizhou, Wang, Haiman, Li, Jian, Zhao, Mengya, Zhou, Xiao, Shi, Xianqing, Ye, Baning, Liu, Manli, Wu, Jing, Fu, Yongjian, Long, Dali, Pan, Yu, Wang, Jinlong, Mei, Huaxian, Zhang, Songsong, Wen, Mingxiang, Yang, Enyu, Mu, Sijie, Li, Jianquan, Hu, Tingting, Qin, Bingyu, Li, Min, Wang, Cunzhen, Dong, Xin, Wang, Kaiwu, Wang, Haibo, Yang, Jianxu, Wang, Chuanyao, Wang, Dongxin, Li, Nan, Yu, Zhui, Xu, Song, Yao, Lan, Hou, Guo, Liu, Zhou, Lu, Liping, Lian, Yingtao, Wang, Chunting, Zhang, Jichen, Ding, Ruiqi, Qi, Guoqing, Wang, Qizhi, Wang, Peng, Meng, Zhaoli, Chen, Man, Hu, Xiaobo, He, Xiandi, Zhao, Shibing, Hang, Lele, Li, Rui, Qin, Suhui, Lu, Kun, Dun, Shijuan, Liu, Cheng, Zhou, Qi, Chen, Zhenzhen, Mei, Jing, Zhang, Minwei, Xu, Hao, Lin, Jincan, Shi, Qindong, Fu, Lijuan, Zeng, Qinjing, Ma, Hongye, Yan, Jinqi, Gao, Lan, Liu, Hongjuan, Zhang, Lei, Li, Hao, He, Xiaona, Fan, Jingqun, Guo, Litao, Liu, Yu, Wang, Xue, Sun, Jingjing, Liu, Zhongmin, Yang, Juan, Ding, Lili, Sheng, Lulu, Liu, Xingang, Yan, Jie, Wang, Quihui, Wang, Yifeng, Zhao, Dan, Zhao, Shuangping, Hu, Chenghuan, Li, Jing, Deng, Fuxing, Qui, Haibo, Yang, Yi, Mo, Min, Pan, Chun, Wu, Changde, Huang, Yingzi, Huang, Lili, Liu, Airan, Korhonen, Anna-Maija, Törnblom, Sanna, Sutinen, Sari, Pettilä, Leena, Heinonen, Jonna, Lappi, Eliria, Suhonen, Taria, Karlsson, Sari, Hoppu, Sanna, Jalkanen, Ville, Kuitunen, Anne, Levoranta, Markus, Långsjö, Jaakko, Ristimäki, Sanna, Malila, Kaisa, Wootten, Anna, Varila, Simo, Järvisalo, Mikko J., Inkinen, Outi, Kentala, Satu, Leivo, Keijo, Haltia, Paivi, Ricard, Jean-Damien, Messika, Jonathan, Tiagarajah, Abirami, Emery, Malo, Dechanet, Aline, Gernez, Coralie, Roux, Damien, Martin-Lefevre, Laurent, Fiancette, Maud, Vinatier, Isabelle, Lacherade, Jean Claude, Colin, Gwenhaël, Lebert, Christine, Azais, Marie-Ange, Yehia, Aihem, Pouplet, Caroline, Lagarrigue, Matthieu Henry, Seguin, Amélie, Crosby, Laura, Maizel, Julien, Titeca-Beauport, Dimitri, Combes, Alain, Nieszkowska, Ania, Masi, Paul, Demoule, Alexandre, Mayaux, Julien, Dres, Martin, Morawiec, Elise, Decalvele, Maxens, Demiri, Suela, Faure, Morgane, Marios, Clémence, Mallet, Maxime, Ordon, Marie Amélie, Morizot, Laura, Cantien, Marie, Pousset, François, Poirson, Florent, Cohen, Yves, Argaud, Laurent, Cour, Martin, Bitker, Laurent, Simon, Marie, Hernu, Romain, Baudry, Thomas, De La Salle, Sylvie, Robine, Adrien, Sedillot, Nicholas, Tchenio, Xavier, Bouisse, Camille, Roux, Sylvie, Barbar, Saber Davide, Trusson, Rémi, Tamion, Fabienne, Grangé, Steven, Carpentier, Dorothée, Chevrel, Guillaume, Ensenyat-Martin, Luis, Marque, Sophie, Quenot, Jean-Pierre, Andreu, Pascal, Dargent, Auguste, Large, Audrey, Chudeau, Nicolas, Landais, Mickael, Derrien, Benoit, Callahan, Jean Christophe, Guitton, Christophe, Le Moal, Charlène, Robert, Alain, Asehnoune, Karim, Cinotti, Raphaël, Grillot, Nicolas, Demeure, Dominique, Vinsonneau, Christophe, Rahmani, Imen, Marzouk, Mehdi, Dekeyser, Thibault, Sejourne, Caroline, Verlay, Mélanie, Thevenin, Fabienne, Delecolle, Lucie, Thevenin, Didier, Souweine, Bertrand, Coupez, Elisabeth, Adda, Mireille, Eraldi, Jean-Pierre, Marchalot, Antoine, De Prost, Nicolas, Dessap, Armand Mekontso, Razazi, Keyvan, Meziani, Ferhat, Boisrame-Helms, Julie, Clere-Jehl, Raphael, Delabranche, Xavier, Kummerlen, Christine, Merdji, Hamid, Monnier, Alexandra, Rabouel, Yannick, Rahmani, Hassene, Allam, Hayat, Chenaf, Samir, Franja, Vincenta, Pons, Bertrand, Carles, Michel, Martino, Frédéric, Richard, Régine, Zuber, Benjamin, Lacave, Guillaume, Lakhal, Karim, Rozec, Bertrand, Van, Hoa Dang, Boulet, Éric, Fadel, Fouad, Cleophax, Cedric, Dufour, Nicolas, Grant, Caroline, Thuong, Marie, Reignier, Jean, Canet, Emmanuel, Nicolet, Laurent, Boulain, Thierry, Nay, Mai-Anh, Benzekri, Dalila, Barbier, François, Bretagnol, Anne, Kamel, Toufik, Mathonnet, Armelle, Muller, Grégoire, Skarzynski, Marie, Rossi, Julie, Pradet, Amandine, Dos Santos, Sandra, Guery, Aurore, Muller, Lucie, Felix, Luis, Bohé, Julien, Thiéry, Guillaume, Aissaoui, Nadia, Vimpere, Damien, Commeureuc, Morgane, Diehl, Jean-Luc, Guerot, Emmanuel, Liangos, Orfeas, Wittig, Monika, Zarbock, Alexander, Küllmar, Mira, van Waegeningh, Thomas, Rosenow, Nadine, Brickell, Kathy, Doran, Peter, Murray, Patrick T., Landoni, Giovanni, Lembo, Rosalba, Zangrillo, Alberto, Monti, Giacomo, Tozzi, Margherita, Marzaroli, Matteo, Lombardi, Gaetano, Paternoster, Gianluca, Vitiello, Michelangelo, Parke, Rachael, Butler, Magdalena, Gilder, Eileen, Cowdrey, Keri-Anne, Wallace, Samantha, Hallion, Jane, Woolett, Melissa, Neal, Philippa, Duffy, Karina, Long, Stephanie, McArthur, Colin, Simmonds, Catherine, Chen, Yan, McConnochie, Rachael, Newby, Lynette, Knight, David, Henderson, Seton, Mehrtens, Jan, Morgan, Stacey, Morris, Anna, Vander Hayden, Kymbalee, Burke, Tara, Bailey, Matthew, Freebairn, Ross, Chadwick, Lesley, Park, Penelope, Rolls, Christine, Thomas, Liz, Buehner, Ulrike, Williams, Erin, Albrett, Jonathan, Kirkham, Simon, Jackson, Carolyn, Browne, Troy, Goodson, Jennifer, Jackson, David, Houghton, James, Callender, Owen, Higson, Vicki, Keet, Owen, Dominy, Clive, Young, Paul, Hunt, Anna, Judd, Harriet, Lawrence, Cassie, Olatunji, Shaanti, Robertson, Yvonne, Latimer-Bell, Charlotte, Hendry, Deborah, Mckay-Vucago, Agnes, Beehre, Nina, Lesona, Eden, Navarra, Leanlove, Robinson, Chelsea, Jang, Ryan, Junge, Andrea, Lambert, Bridget, Thibault, Michel, Eckert, Philippe, Kissling, Sébastien, Polychronopoulos, Erietta, Poli, Elettra, Altarelli, Marco, Schnorf, Madeleine, Mallaird, Samia Abed, Heidegger, Claudia, Perret, Aurelie, Montillier, Philippe, Sangla, Frederic, Neils, Seigenthaller, De Watteville, Aude, Phull, Mandeep-Kaur, George, Aparna, Hussain, Nauman, Pogreban, Tatiana, Lobaz, Steve, Daniels, Alison, Cunningham, Mishell, Kerr, Deborah, Nicholson, Alice, Shanmugasundaram, Pradeep, Abrams, Judith, Manso, Katarina, Hambrook, Geraldine, McKerrow, Elizabeth, Salva, Juvy, Foulkes, Stephen, Wise, Matthew, Morgan, Matt, Brooks, Jenny, Cole, Jade, Davies, Tracy Michelle, Hill, Helen, Thomas, Emma, Vizcaychipi, Marcela, Baharlo, Behrad, Carungcong, Jaime, Costa, Patricia, Martins, Laura, Kapoor, Ritoo, Hazelton, Tracy, Moon, Angela, Musselwhite, Janine, Shelley, Ben, McCall, Philip, Arbane, Gill, Bociek, Aneta, Marotti, Martina, Lim, Rosario, Campos, Sara, Novellas, Neus Grau, Cennamo, Armando, Slack, Andrew, Wyncoll, Duncan, Camporota, Luigi, Sparkes, Simon, Tilley, Rosalinde, Rattray, Austin, Moreland, Gayle, Duffy, Jane, McGonigal, Elizabeth, Hopkins, Philip, Finney, Clare, Smith, John, Noble, Harriet, Watson, Hayley, Harris, Claire-Louise, Clarey, Emma, Corcoran, Eleanor, Beck, James, Howcroft, Clare, Youngs, Nora, Wilby, Elizabeth, Ogg, Bethan, Wolverson, Adam, Lee, Sandra, Butler, Susie, Okubanjo, Maryanne, Hindle, Julia, Welters, Ingeborg, Williams, Karen, Johnson, Emily, Patrick-Heselton, Julie, Shaw, David, Waugh, Victoria, Stewart, Richard, Mwaura, Esther, Wren, Lynn, Mew, Louise, Sutherland, Sara-Beth, Adderley, Jane, Ruddy, Jim, Harkins, Margaret, Kaye, Callum, Scott, Teresa, Mitchell, Wendy, Anderson, Felicity, Willox, Fiona, Jagannathan, Vijay, Clark, Michele, Purv, Sarah, Sharman, Andrew, Meredith, Megan, Ryan, Lucy, Conner, Louise, Peters, Cecilia, Harvey, Dan, Roshdy, Ashraf, Collins, Amy, Sim, Malcolm, Henderson, Steven, Chee, Nigel, Pitts, Sally, Bowman, Katie, Dilawershah, Maria, Vamplew, Luke, Howe, Elizabeth, Rogers, Paula, Hernandez, Clara, Prendergast, Clara, Benton, Jane, Rosenberg, Alex, Forni, Lui G., Grant, Alice, Carvelli, Paula, Raithatha, Ajay, Bird, Sarah, Richardson, Max, Needham, Matthew, Hirst, Claire, Ball, Jonathan, Leaver, Susannah, Howlett, Luisa, Delgado, Carlos Castro, Farnell-Ward, Sarah, Farrah, Helen, Gray, Geraldine, Joseph, Gipsy, Robinson, Francesca, Tridente, Ascanio, Harrop, Clare, Shuker, Karen, McLaughlan, Derek, Ramsey, Judith, Meehan, Sharon, Rose, Bernd Oliver, Reece-Anthony, Rosie, Gurung, Babita, Whitehouse, Tony, Snelson, Catherine, Veenith, Tonny, Johnston, Andy, Cooper, Lauren, Carrera, Ron, Ellis, Karen, Fellows, Emma, Harkett, Samanth, Bergin, Colin, Spruce, Elaine, Despy, Liesl, Goundry, Stephanie, Dooley, Natalie, Mason, Tracy, Clark, Amy, Dignam, Gemma, Ward, Geraldine, Attwood, Ben, Parsons, Penny, Mason, Sophie, Margarson, Michael, Lord, Jenny, McGlone, Philip, Hodgson, Luke E., Chadbourn, Indra, Gomez, Raquel, Margalef, Jordi, Pretorius, Rinus, Hamshere, Alexandra, Carter, Joseph, Cahill, Hazel, Grainger, Lia, Howard, Kate, Forshaw, Greg, Guy, Zoe, Kashani, Kianoush B., Albright, Robert C., Amsbaugh, Amy, Stoltenberg, Anita, Niven, Alexander S., Lynch, Matthew, O’Mara, AnnMarie, Naeem, Syed, Sharif, Sairah, Goulart, Joyce McKenney, Tolwani, Ashita, Lyas, Claretha, Latta, Laura, Bihorac, Azra, Hashemighouchani, Haleh, Efron, Philip, Ruppert, Matthew, Cupka, Julie, Kiley, Sean, Carson, Joshua, White, Peggy, Omalay, George, Brown, Sherry, Velez, Laura, Marceron, Alina, Neyra, Javier A., Aycinena, Juan Carlos, Elias, Madona, Ortiz-Soriano, Victor M., Hauschild, Caroline, Dorfman, Robert, Investigators, STARRT-AKI, Investigators, STARRT-AKI, Zampieri Fernando, G, da Costa Bruno, R, Vaara Suvi, T, Lamontagne, Françoi, Rochwerg, Bram, Nichol Alistair, D, Mcguinness, Shay, McAuley Danny, F, Ostermann, Marlie, Wald, Ron, Bagshaw Sean, M, STARRT-AKI, Investigator, Landoni, G, and Zangrillo, A

Subjects
Kidney-replacement therapy, Critical Illness, Acute Kidney Injury/therapy, Randomized, Bayes Theorem, Acute Kidney Injury, Critical Care and Intensive Care Medicine, Bayesian, Trial, Acute kidney injury, Renal Replacement Therapy, Renal Replacement Therapy/methods, Critical Illness/therapy, Medicine and Health Sciences, Humans, Mortality, Dialysis, Probability
Abstract

Background Timing of initiation of kidney-replacement therapy (KRT) in critically ill patients remains controversial. The Standard versus Accelerated Initiation of Renal-Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial compared two strategies of KRT initiation (accelerated versus standard) in critically ill patients with acute kidney injury and found neutral results for 90-day all-cause mortality. Probabilistic exploration of the trial endpoints may enable greater understanding of the trial findings. We aimed to perform a reanalysis using a Bayesian framework. Methods We performed a secondary analysis of all 2927 patients randomized in multi-national STARRT-AKI trial, performed at 168 centers in 15 countries. The primary endpoint, 90-day all-cause mortality, was evaluated using hierarchical Bayesian logistic regression. A spectrum of priors includes optimistic, neutral, and pessimistic priors, along with priors informed from earlier clinical trials. Secondary endpoints (KRT-free days and hospital-free days) were assessed using zero–one inflated beta regression. Results The posterior probability of benefit comparing an accelerated versus a standard KRT initiation strategy for the primary endpoint suggested no important difference, regardless of the prior used (absolute difference of 0.13% [95% credible interval [CrI] − 3.30%; 3.40%], − 0.39% [95% CrI − 3.46%; 3.00%], and 0.64% [95% CrI − 2.53%; 3.88%] for neutral, optimistic, and pessimistic priors, respectively). There was a very low probability that the effect size was equal or larger than a consensus-defined minimal clinically important difference. Patients allocated to the accelerated strategy had a lower number of KRT-free days (median absolute difference of − 3.55 days [95% CrI − 6.38; − 0.48]), with a probability that the accelerated strategy was associated with more KRT-free days of 0.008. Hospital-free days were similar between strategies, with the accelerated strategy having a median absolute difference of 0.48 more hospital-free days (95% CrI − 1.87; 2.72) compared with the standard strategy and the probability that the accelerated strategy had more hospital-free days was 0.66. Conclusions In a Bayesian reanalysis of the STARRT-AKI trial, we found very low probability that an accelerated strategy has clinically important benefits compared with the standard strategy. Patients receiving the accelerated strategy probably have fewer days alive and KRT-free. These findings do not support the adoption of an accelerated strategy of KRT initiation.

Published
2022

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

Author

Writing Committee for the REMAP-CAP Investigators, Estcourt, Lise J, Turgeon, Alexis F, McQuilten, Zoe K, McVerry, Bryan J, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Arnold, Donald M, Beane, Abigail, Bégin, Philippe, van Bentum-Puijk, Wilma, Berry, Lindsay R, Bhimani, Zahra, Birchall, Janet E, Bonten, Marc JM, Bradbury, Charlotte A, Brunkhorst, Frank M, Buxton, Meredith, Callum, Jeannie L, Chassé, Michaël, Cheng, Allen C, Cove, Matthew E, Daly, James, Derde, Lennie, Detry, Michelle A, De Jong, Menno, Evans, Amy, Fergusson, Dean A, Fish, Matthew, Fitzgerald, Mark, Foley, Claire, Goossens, Herman, Gordon, Anthony C, Gosbell, Iain B, Green, Cameron, Haniffa, Rashan, Harvala, Heli, Higgins, Alisa M, Hills, Thomas E, Hoad, Veronica C, Horvat, Christopher, Huang, David T, Hudson, Cara L, Ichihara, Nao, Laing, Emma, Lamikanra, Abigail A, Lamontagne, François, Lawler, Patrick R, Linstrum, Kelsey, Litton, Edward, Lorenzi, Elizabeth, MacLennan, Sheila, Marshall, John, McAuley, Daniel F, McDyer, John F, McGlothlin, Anna, McGuinness, Shay, Miflin, Gail, Montgomery, Stephanie, Mouncey, Paul R, Murthy, Srinivas, Nichol, Alistair, Parke, Rachael, Parker, Jane C, Priddee, Nicole, Purcell, Damian FJ, Reyes, Luis F, Richardson, Peter, Robitaille, Nancy, Rowan, Kathryn M, Rynne, Jennifer, Saito, Hiroki, Santos, Marlene, Saunders, Christina T, Serpa Neto, Ary, Seymour, Christopher W, Silversides, Jon A, Tinmouth, Alan A, Triulzi, Darrell J, Turner, Anne M, van de Veerdonk, Frank, Walsh, Timothy S, Wood, Erica M, Berry, Scott, Lewis, Roger J, Menon, David K, McArthur, Colin, Zarychanski, Ryan, Angus, Derek C, Webb, Steve A, Roberts, David J, Shankar-Hari, Manu, Menon, David [0000-0002-3228-9692], Apollo - University of Cambridge Repository, Investigators, Writing Committee for the REMAP-CAP, Writing Comm REMAP-CAP Investigators, Hôpital Raymond Poincaré [AP-HP], Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil (UVSQ Santé), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), National Institutes of Health, NIH, National Institute of Child Health and Human Development, NICHD, Pittsburgh Foundation, Breast Cancer Research Foundation, BCRF, Bristol-Myers Squibb, BMS, GlaxoSmithKline, GSK, Medtronic, Baxter International, Manitoba Medical Service Foundation, MMSF, CancerCare Manitoba Foundation, CCMF, Wellcome Trust, WT, University of Manitoba, UM, Health Research Board, HRB: PHRC-20-0147, National Blood Authority, NBA, Llywodraeth Cymru, Translational Breast Cancer Research Consortium, TBCRC, Canadian Institutes of Health Research, IRSC: 158584, CTN 2014-012, Medical Research Council, MRC, National Institute for Health Research, NIHR, Department of Health and Social Care, DH, European Commission, EC: APP194811, National Heart and Lung Institute, NHLI, National Health and Medical Research Council, NHMRC: 2015-06-18, 2016-16-011, APP1101719, APP2002132, Health Research Council of New Zealand, HRC: 16/631, 447335, Monash University, MU, Ministère des Affaires Sociales et de la Santé: 215522, Seventh Framework Programme, FP7, Université Pierre et Marie Curie, UPMC, Innovate UK, Horizon 2020, Pharmaceuticals Bayer, Minderoo Foundation, Dr Fitzgerald reported receiving grants from the PREPARE Network and the European Commission. Dr Gordon reported receiving grants from the National Institute for Health Research and receiving personal fees from 30 Respiratory, GlaxoSmithKline, and Bristol Myers Squibb. Dr Gosbell reported receiving grants from the Australian Red Cross Lifeblood, which is funded by the Australian government. Dr Haniffa reported receiving grants from the Wellcome Trust Innovations Project, the Minderoo Foundation, and the UK Research and Innovation African Critical Care Registry Network. Dr Higgins reported receiving grants from the National Health and Medical Research Council, the Minderoo Foundation, and the National Blood Authority. Dr Hills reported receiving grants from the Health Research Council of New Zealand. Dr Hoad reported receiving grants from the Australian Red Cross Lifeblood, which is funded by the Australian government. Dr Horvat reported receiving grants from the National Institute of Child Health and Human Development. Dr Huang reported receiving grants from the Breast Cancer Research Foundation. Dr Lamontagne reported receiving grants from the Canadian Institutes of Health Research. Dr Lawler reported receiving consulting fees from Novartis, Coronna LLC, and Brigham and Women’s Hospital, receiving royalties from McGraw-Hill Publishing, and receiving grants from the Canadian Institutes of Health Research, the LifeArc Foundation, the National Institutes of Health, the Peter Munk Cardiac Centre, the Ted Rogers Centre for Heart Research, the Thistledown Foundation, and the province of Ontario. Dr Lorenzi reported receiving personal fees from Berry Consultants. Dr Marshall reported receiving personal fees from AM-Pharma (data and safety monitoring board chair) and Critical Care Medicine (associate editor). Dr McAuley reported receiving personal fees from Bayer, GlaxoSmithKline, Boehringer Ingelheim, Novartis, Eli Lilly, Vir Biotechnology, Faron Pharmaceuticals, and Sobi, receiving grants from the National Institute for Health Research, Wellcome Trust, Innovate UK, the Medical Research Council, and the Northern Ireland Health and Social Care Research and Development Division, and holding a patent for an anti-inflammatory treatment that was issued to Queen’s University Belfast. Dr McGlothlin reported receiving grants from the PREPARE Network, the European Commission, and the Global Coalition for Adapative Research. Mr Mouncey reported receiving grants from the European Union, the PREPARE Network, the National Institute for Health Research, and European Union Horizon 2020. Dr Nichol reported receiving grants from the Health Research Board of Ireland and Baxter and receiving personal fees from AM-Pharma. Dr Parke reported receiving grants from Fisher and Paykel Healthcare Ltd. Ms Parker reported receiving grants from Monash University. Mr Richardson reported receiving funding from the Welsh government. Dr Rowan reported receiving grants from the European Commission and the National Institute for Health Research. Dr Saunders reported receiving grants from the PREPARE Network, the European Commission, and the Global Coalition for Adapative Research. Dr Serpa Neto reported receiving personal fees from Drager and Endpoint Health. Dr Tinmouth reported receiving grants and personal fees from the Canadian Blood Services. Ms Turner reported receiving grants from the Health Research Council of New Zealand. Dr van de Veerdonk reported receiving personal fees from Gilead, Sobi, and GlaxoSmithKline. Dr Wood reported receiving grants from the Australian Medical Research Future Fund. Dr S. Berry reported being an employee of Berry Consultants with an ownership role. Dr Lewis reported being an employee of Berry Consultants. Dr Menon reported receiving grants from the National Institute for Health Research. Dr McArthur reported receiving grants from the Health Research Council of New Zealand. Dr Zarychanski reported receiving grants from the Canadian Institutes of Health Research, the University of Manitoba, LifeArc, the Thistledown Foundation, Research Manitoba, the CancerCare Manitoba Foundation, the Victoria General Hospital Foundation, the Peter Munk Cardiac Centre, and the Manitoba Medical Services Foundation. Dr Webb reported receiving grants from the National Health and Medical Research Council and the Minderoo Foundation. Dr Shankar-Hari reported receiving grants from the National Institute for Clinical Research. No other disclosures were reported., nonprofit sponsors: Monash University, Melbourne, Australia (Australasian sponsor), Utrecht Medical Center, Utrecht, the Netherlands (European sponsor), St Michael’s Hospital, Toronto, Ontario, Canada (Canadian sponsor), and the Global Coalition for Adaptive Research, San Francisco, California (US sponsor). This study was additionally funded by grant 602525 FP7-health-2013-innovation-1 from the European Union Platform for European Preparedness Against Reemerging Epidemics, grants APP1101719 and APP1116530 from the Australian National Health and Medical Research Council, grant APP2002132 from the Australian Medical Research Future Fund, grant 16/631 from the New Zealand Health Research Council, grant 447335 from the Canadian Institutes of Health Research COVID-19 Rapid Research, grant 158584 from the Canadian Institutes of Health Research Strategy for Patient-Oriented Research Innovative Clinical Trials Program, grant CTN 2014-012 from the Health Research Board of Ireland, grant PHRC-20-0147 from the French Ministry of Health, and grant 215522 from the Wellcome Trust Innovations Project and funding from the National Institute for Health Research, the Department of Health and Social Care, the EU Programme Emergency Support Instrument, the NHS Blood and Transplant Research and Development Programme, the National Institute for Health Research, the National Institute for Health Research Imperial Biomedical Research Centre, the UPMC Learning While Doing Program, the Translational Breast Cancer Research Consortium, the Pittsburgh Foundation, and the Minderoo Foundation. The Australian government funds the Australian Red Cross Lifeblood for the provision of blood products and services. The collection of plasma in the United Kingdom was funded by European Union SoHo grants from the Department of Health and Social Care. Dr Turgeon is the Canada Research Chair in Critical Care Neurology and Trauma. Dr McQuilten is supported by emerging leader fellowship APP194811 from the National Health and Medical Research Council. Dr Gordon is funded by research professorship 2015-06-18 from the National Institute for Health Research. Dr Shankar-Hari is funded by clinician scientist fellowship 2016-16-011 from the National Institute for Health Research., In Canada, the trial has been funded by the Canadian Institute of Health Research, Strategy for Patient-Oriented Research (CIHR-SPOR) Innovative Clinical Trials Program Grant (no. 158584) for CAD $1,497,200, for the recruitment of 300 patients., The Platform for European Preparedness Against (Re-)emerging Epidemics (PREPARE) consortium is funded by the European Union (FP7-HEALTH-2013-INNOVATION-1, grant number 602525). Within the PREPARE consortium, the trial has funding for the recruitment of approximately 4000 patients., REMAP-CAP was supported in the Netherlands by the Research Collaboration Critical Care the Netherlands (RCC-Net)., Funding sources for the REMAP-CAP trial are specified in the core protocol documents. This domain has received domain-specific funding from the Australian Medical Research Future Fund (MRFF)., reported receiving grants from the National Institute for Health Research and European Union Horizon 2020. Dr Turgeon reported receiving grants from the Canadian Institutes of Health Research. Dr McQuilten reported receiving grants from the Australian Medical Research Future Fund. Dr McVerry reported receiving grants from the Pittsburgh Foundation, the Translational Breast Cancer Research Consortium, UPMC Learning While Doing Program, National Heart, Lung, and Blood Institute, and Bayer Pharmaceuticals and receiving personal fees from Boehringer Ingelheim. Dr Annane reported receiving grants from the French Ministry of Health and Solidarity. Dr Arnold reported receiving grants from the Canadian Institutes of Health Research. Ms Beane reported receiving grants and salary support from Wellcome Trust. Ms Bentum-Puijk reported receiving grants from the European Commission and the European Union. Dr L. Berry reported receiving grants from Berry Consultants. Dr Bradbury reported receiving personal fees from Lilly, Bristol Myers Squibb, Pfizer, Bayer, Amgen, Novartis, Janssen, Portola Advisors, and Ablynx. Dr Buxton reported receiving personal fees from the Breast Cancer Research Foundation, Amgen, and Eisai. Dr Callum reported receiving grants from the Canadian Blood Services and Octapharma. Dr Cove reported receiving grants from National University Health System, receiving consulting fees from Medtronic and Baxter, and holding a US patent for removal of carbon dioxide via dialysis. Dr Daly reported receiving grants from the Australian Red Cross Lifeblood, which is funded by the Australian government. Dr Derde reported receiving grants from University Medical Center Utrecht, being a member of the COVID-19 guideline committee of the Surviving Sepsis Campaign/ European Society of Intensive Care Medicine and European Society of Intensive Care Medicine COVID-19 taskforce, and serving as chair of the Dutch intensivists taskforce acute infectious threats. Dr Detry reported receiving grants from the European Union Platform for European Preparedness Against Reemerging Epidemics (PREPARE) consortium, the Australian National Health and Medical Research Council, the Health Research Council of New Zealand, and the UPMC Learning While Doing Program. Dr De Jong reported receiving personal fees from Roche Scientific, Shionogi Scientific, and Janssen., The current regions are: x Europe, with funding from a European Union FP7 grant (FP7-HEALTH-2013-INNOVATION-1, grant number 602525), to support the enrollment of 4000 participants. This funding terminates in 2021. x Australia and New Zealand. In Australia the project has received funding from a NHMRC Project Grant (APP1101719), to support the enrollment of 2000 participants. This funding terminates in December 2021, although some extension may be feasible. In New Zealand the project has received funding from a HRC Programme Grant (16/631), to support the enrollment of 800 participants. This funding terminates in November 2021. x Canada. In Canada the project has received funding for a CIHR grant (158584), to support the enrollment of 300 participants. This funding terminates in 2022. x United States. In the US, funding has been received from UPMC health system for recruitment internally at all UPMC hospitals (>40) and to support a US regional coordinating center. Philanthropic support is being provided through GCAR. Additional funds are being pursued., The REMAP-CAP platform is supported by the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Canadian Critical Care Trials Group, the Irish Critical Care, European Project: 602525,EC:FP7:HEALTH,FP7-HEALTH-2013-INNOVATION-1,PREPARE(2014), NIHR, National Institute for Health Research, Medical Microbiology and Infection Prevention, AII - Infectious diseases, and Intensive Care Medicine

Subjects
Male, medicine.medical_treatment, [SDV]Life Sciences [q-bio], lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], 030204 cardiovascular system & hematology, Logistic regression, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Critical Illness/therapy, Vasoconstrictor Agents, 030212 general & internal medicine, Hospital Mortality, Treatment Failure, 11 Medical and Health Sciences, Original Investigation, Mortality rate, General Medicine, Middle Aged, Intensive care unit, Writing Committee for the REMAP-CAP Investigators, 3. Good health, Female, Life Sciences & Biomedicine, COVID-19/therapy, Adult, medicine.medical_specialty, Randomization, Respiration, Artificial/statistics & numerical data, Critical Illness, ABO Blood-Group System, 03 medical and health sciences, Medicine, General & Internal, Internal medicine, General & Internal Medicine, medicine, Humans, Adverse effect, COVID-19 Serotherapy, Aged, Mechanical ventilation, Science & Technology, business.industry, Immunization, Passive, Vasoconstrictor Agents/therapeutic use, COVID-19, Odds ratio, Length of Stay, Respiration, Artificial, Logistic Models, Human medicine, business
Abstract

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

Published
2021

12. Adverse Events After Transition From ICU to Hospital Ward: A Multicenter Cohort Study.

Author

Sauro, Khara M., Soo, Andrea, de Grood, Chloe, Yang, Michael M. H., Wierstra, Benjamin, Benoit, Luc, Couillard, Philippe, Lamontagne, François, Turgeon, Alexis F., Forster, Alan J., Fowler, Robert A., Dodek, Peter M., Bagshaw, Sean M., and Stelfox, Henry T.

Subjects
*HOSPITAL wards, *ADVERSE health care events, *COHORT analysis, *LENGTH of stay in hospitals, *MEDICAL records
Abstract

Objectives: To examine adverse events and associated factors and outcomes during transition from ICU to hospital ward (after ICU discharge).Design: Multicenter cohort study.Setting: Ten adult medical-surgical Canadian ICUs.Patients: Patients were those admitted to one of the 10 ICUs from July 2014 to January 2016.Interventions: None.Measurements and Main Results: Two ICU physicians independently reviewed progress and consultation notes documented in the medical record within 7 days of patient's ICU discharge date to identify and classify adverse events. The adverse event data were linked to patient characteristics and ICU and ward physician surveys collected during the larger prospective cohort study. Analyses were conducted using multivariable logistic regression. Of the 451 patients included in the study, 84 (19%) experienced an adverse event, the majority (62%) within 3 days of transfer from ICU to hospital ward. Most adverse events resulted only in symptoms (77%) and 36% were judged to be preventable. Patients with adverse events were more likely to be readmitted to the ICU (odds ratio, 5.5; 95% CI, 2.4-13.0), have a longer hospital stay (mean difference, 16.1 d; 95% CI, 8.4-23.7) or die in hospital (odds ratio, 4.6; 95% CI, 1.8-11.8) than those without an adverse event. ICU and ward physician predictions at the time of ICU discharge had low sensitivity and specificity for predicting adverse events, ICU readmissions, and hospital death.Conclusions: Adverse events are common after ICU discharge to hospital ward and are associated with ICU readmission, increased hospital length of stay and death and are not predicted by ICU or ward physicians. [ABSTRACT FROM AUTHOR]

Published
2020
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