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Randomized Controlled Trial
Rapidly Improving Acute Respiratory Distress Syndrome in Therapeutic Randomized Controlled Trials.
- Edward J Schenck, Clara Oromendia, Lisa K Torres, David A Berlin, Choi Augustine M K AMK Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornel, and Ilias I Siempos.
- Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medicine, New York, NY.
- Chest. 2019 Mar 1; 155 (3): 474-482.
BackgroundObservational studies suggest that some patients meeting criteria for ARDS no longer fulfill the oxygenation criterion early in the course of their illness. This subphenotype of rapidly improving ARDS has not been well characterized. We attempted to assess the prevalence, characteristics, and outcomes of rapidly improving ARDS and to identify which variables are useful to predict it.MethodsA secondary analysis was performed of patient level data from six ARDS Network randomized controlled trials. We defined rapidly improving ARDS, contrasted with ARDS > 1 day, as extubation or a Pao2 to Fio2 ratio (Pao2:Fio2) > 300 on the first study day following enrollment.ResultsThe prevalence of rapidly improving ARDS was 10.5% (458 of 4,361 patients) and increased over time. Of the 1,909 patients enrolled in the three most recently published trials, 197 (10.3%) were extubated on the first study day, and 265 (13.9%) in total had rapidly improving ARDS. Patients with rapidly improving ARDS had lower baseline severity of illness and lower 60-day mortality (10.2% vs 26.3%; P < .0001) than ARDS > 1 day. Pao2:Fio2 at screening, change in Pao2:Fio2 from screening to enrollment, use of vasopressor agents, Fio2 at enrollment, and serum bilirubin levels were useful predictive variables.ConclusionsRapidly improving ARDS, mostly defined by early extubation, is an increasingly prevalent and distinct subphenotype, associated with better outcomes than ARDS > 1 day. Enrollment of patients with rapidly improving ARDS may negatively affect the prognostic enrichment and contribute to the failure of therapeutic trials.Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.
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