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Early Restrictive or Liberal Fluid Management for Sepsis-Induced Hypotension.

, Nathan I Shapiro1, Ivor S Douglas1

  • 1From the Department of Emergency Medicine, Beth Israel Deaconess Medical Center-Harvard Medical School (N.I.S.), the Biostatistics Center (D.H., W.H., P.L.) and the Department of Medicine (K.O., N.R., B.T.T.), Massachusetts General Hospital, and the Department of Anesthesia, Critical Care, and Pain Medicine, Beth Israel Deaconess Medical Center (D.T.), Boston, and the Department of Medicine, Baystate Medical Center, Springfield (J.S.S.) - all in Massachusetts; the Department of Medicine, Denver Health Medical Center, Denver (I.S.D.), and the Department of Emergency Medicine, University of Colorado School of Medicine, Aurora (A.A.G.) - both in Colorado; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (R.G.B., T.J.I.); the Department of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, and the Department of Medicine, University of Utah, Salt Lake City - both in Utah (S.M.B., C.K.G.); the Ohio State University Wexner Medical Center, Columbus (M.C.E.); the Department of Medicine, Montefiore Medical Center, Bronx, NY (M.N.G.); the Department of Medicine, Oregon Health and Science University, Portland (C.L.H., A.K.); the Department of Emergency Medicine, University of Mississippi Medical Center, Jackson (A.E.J.); the Department of Medicine, University of California, San Francisco, Medical Center, San Francisco (K.D.L.); the Department of Emergency Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC (C.D.M.); the Department of Surgery, University of Michigan Medical School, Ann Arbor (P.K.P.); the Departments of Medicine (T.W.R., M.W.S.) and Emergency Medicine (W.H.S.), Vanderbilt University Medical Center, Nashville; and the Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh (D.M.Y.).

The New England Journal of Medicine
|January 23, 2023
PubMed
Summary

In sepsis resuscitation, a restrictive fluid strategy did not significantly reduce 90-day mortality compared to a liberal fluid strategy. Both approaches showed similar safety outcomes in patients with sepsis-induced hypotension.

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Area of Science:

  • Critical Care Medicine
  • Emergency Medicine
  • Clinical Trials

Background:

  • Sepsis management commonly involves intravenous fluids and vasopressors.
  • Limited comparative data exist for prioritizing fluid versus vasopressor delivery in early sepsis resuscitation.
  • Sepsis-induced hypotension requires timely and effective treatment strategies.

Purpose of the Study:

  • To compare the efficacy and safety of a restrictive fluid strategy versus a liberal fluid strategy in patients with sepsis-induced hypotension.
  • To determine if prioritizing vasopressors with lower fluid volumes (restrictive) reduces 90-day mortality compared to prioritizing higher fluid volumes before vasopressors (liberal).

Main Methods:

  • An unblinded superiority trial randomized 1563 patients with sepsis-induced hypotension to either a restrictive or liberal fluid strategy for 24 hours.
  • Randomization occurred within 4 hours of meeting criteria for hypotension refractory to initial fluid resuscitation.
  • The primary outcome was all-cause mortality before hospital discharge by day 90; safety was also assessed.

Main Results:

  • The restrictive fluid group received significantly less intravenous fluid (median difference: -2134 ml) and earlier, more prolonged vasopressor use compared to the liberal group.
  • All-cause mortality by day 90 was 14.0% in the restrictive group and 14.9% in the liberal group (estimated difference: -0.9 percentage points; 95% CI, -4.4 to 2.6).
  • The number of serious adverse events was similar between the two groups.

Conclusions:

  • The restrictive fluid strategy did not result in significantly lower (or higher) 90-day mortality compared to the liberal fluid strategy in patients with sepsis-induced hypotension.
  • Both fluid strategies demonstrated comparable safety profiles in this trial.
  • Findings suggest that neither strategy offers a definitive mortality benefit in this patient population.