• Ivor S Douglas, Philip M Alapat, Keith A Corl, Matthew C Exline, Lui G Forni, Andre L Holder, David A Kaufman, Akram Khan, Mitchell M Levy, Gregory S Martin, Jennifer A Sahatjian, Eric Seeley, Wesley H Self, Jeremy A Weingarten, Mark Williams, and Douglas M Hansell.
• Pulmonary Science and Critical Care Medicine, Denver Health Medical Center and University of Colorado, Anschutz Medical Campus, Denver, CO. Electronic address: ivor.douglas@dhha.org.
• Chest. 2020 Oct 1; 158 (4): 1431-1445.

BackgroundFluid and vasopressor management in septic shock remains controversial. In this randomized controlled trial, we evaluated the efficacy of dynamic measures (stroke volume change during passive leg raise) to guide resuscitation and improve patient outcome.Research QuestionWill resuscitation that is guided by dynamic assessments of fluid responsiveness in patients with septic shock improve patient outcomes?Study Design And MethodsWe conducted a prospective, multicenter, randomized clinical trial at 13 hospitals in the United States and United Kingdom. Patients presented to EDs with sepsis that was associated hypotension and anticipated ICU admission. Intervention arm patients were assessed for fluid responsiveness before clinically driven fluid bolus or increase in vasopressors occurred. The protocol included reassessment and therapy as indicated by the passive leg raise result. The control arm received usual care. The primary clinical outcome was positive fluid balance at 72 hours or ICU discharge, whichever occurred first.ResultsIn modified intent-to-treat analysis that included 83 intervention and 41 usual care eligible patients, fluid balance at 72 hours or ICU discharge was significantly lower (-1.37 L favoring the intervention arm; 0.65 ± 2.85 L intervention arm vs 2.02 ± 3.44 L usual care arm; P = .021. Fewer patients required renal replacement therapy (5.1% vs 17.5%; P = .04) or mechanical ventilation (17.7% vs 34.1%; P = .04) in the intervention arm compared with usual care. In the all-randomized intent-to-treat population (102 intervention, 48 usual care), there were no significant differences in safety signals.InterpretationPhysiologically informed fluid and vasopressor resuscitation with the use of the passive leg raise-induced stroke volume change to guide management of septic shock is safe and demonstrated lower net fluid balance and reductions in the risk of renal and respiratory failure. Dynamic assessments to guide fluid administration may improve outcomes for patients with septic shock compared with usual care.Clinical Trial RegistrationNCT02837731.Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

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