Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial

Ivor S. Douglas, 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.
Philip M. Alapat, Pulmonary, Critical Care and Sleep Medicine, Ben Taub Hospital, Houston, TX.
Keith A. Corl, Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.
Matthew C. Exline, Pulmonary, Critical Care and Sleep Medicine, Ohio State University Hospital, Columbus, OH.
Lui G. Forni, Intensive Care Medicine and Nephrology, University of Surrey & Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.
Andre L. Holder, Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.
David A. Kaufman, NYU School of Medicine, New York, NY; Pulmonary and Critical Care Medicine, Bridgeport Hospital, Bridgeport, CT.
Akram Khan, Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland, OR.
Mitchell M. Levy, Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.
Gregory S. Martin, Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.
Jennifer A. Sahatjian, Cheetah Medical, Wilmington, DE.
Eric Seeley, Pulmonary, Critical Care Medicine and Allergy, University of California San Francisco, San Francisco, CA.
Wesley H. Self, Department of Emergency Medicine, Vanderbilt University, Nashville, TN.
Jeremy A. Weingarten, Pulmonary, Critical Care and Sleep Medicine, New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY.
Mark Williams, Pulmonary and Critical Care Medicine, Indiana University School of Medicine, Indianapolis, IN.
Douglas M. Hansell, Cheetah Medical, Wilmington, DE; Department of Anesthesiology, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA.

Document Type

Article

Publication Title

Chest

Abstract

BACKGROUND: Fluid 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 QUESTION: Will resuscitation that is guided by dynamic assessments of fluid responsiveness in patients with septic shock improve patient outcomes? STUDY DESIGN AND METHODS: We 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. RESULTS: In 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. INTERPRETATION: Physiologically 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 REGISTRATION: NCT02837731.

First Page

1431

Last Page

1445

DOI

10.1016/j.chest.2020.04.025

Publication Date

10-1-2020

Identifier

32353418 (pubmed); PMC9490557 (pmc); 10.1016/j.chest.2020.04.025 (doi); S0012-3692(20)30768-6 (pii)

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