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The Restrictive IV Fluid Trial in Severe Sepsis and Septic Shock (RIFTS): A Randomized Pilot Study*

Corl, Keith A. MD, ScM1,2,3; Prodromou, Michael MD1; Merchant, Roland C. MD, MPH, ScD3,4; Gareen, Ilana PhD3; Marks, Sarah MS4; Banerjee, Debasree MD1; Amass, Timothy MD1,3; Abbasi, Adeel MD1,2,3; Delcompare, Cesar BS1; Palmisciano, Amy RN1; Aliotta, Jason MD1; Jay, Gregory MD2; Levy, Mitchell M. MD1

doi: 10.1097/CCM.0000000000003779
Clinical Investigations
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Objectives: It is unclear if a low- or high-volume IV fluid resuscitation strategy is better for patients with severe sepsis and septic shock.

Design: Prospective randomized controlled trial.

Setting: Two adult acute care hospitals within a single academic system.

Patients: Patients with severe sepsis and septic shock admitted from the emergency department to the ICU from November 2016 to February 2018.

Interventions: Patients were randomly assigned to a restrictive IV fluid resuscitation strategy (≤ 60 mL/kg of IV fluid) or usual care for the first 72 hours of care.

Measurements and Main Results: We enrolled 109 patients, of whom 55 were assigned to the restrictive resuscitation group and 54 to the usual care group. The restrictive group received significantly less resuscitative IV fluid than the usual care group (47.1 vs 61.1 mL/kg; p = 0.01) over 72 hours. By 30 days, there were 12 deaths (21.8%) in the restrictive group and 12 deaths (22.2%) in the usual care group (odds ratio, 1.02; 95% CI, 0.41–2.53). There were no differences between groups in the rate of new organ failure, hospital or ICU length of stay, or serious adverse events.

Conclusions: This pilot study demonstrates that a restrictive resuscitation strategy can successfully reduce the amount of IV fluid administered to patients with severe sepsis and septic shock compared with usual care. Although limited by the sample size, we observed no increase in mortality, organ failure, or adverse events. These findings further support that a restrictive IV fluid strategy should be explored in a larger multicenter trial.

1Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.

2Department of Emergency Medicine, Alpert Medical School of Brown University, Providence, RI.

3Brown School of Public Health, Providence, RI.

4Department of Emergency Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.

*See also p. 1004.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Supported, in part, by the Division of Pulmonary and Critical Care and the Department of Emergency Medicine, Alpert Medical School of Brown University.

Dr. Merchant’s institution received funding from the National Institutes of Health. Dr. Jay disclosed he is a Covidien scientific advisory board member. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Address requests for reprints to: Keith Corl, MD, ScM, Department of Medicine, Division of Pulmonary, Critical Care & Sleep, The Rhode Island Hospital, 593 Eddy St, 4th floor, Providence, RI 02903. E-mail: keith_corl@brown.edu

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