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A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: Results of a prospective randomized pilot trial

Schreiber, Martin A. MD; Meier, Eric N. MS; Tisherman, Samuel A. MD; Kerby, Jeffrey D. MD, PhD; Newgard, Craig D. MD, MPH; Brasel, Karen MD; Egan, Debra MSc, MPH; Witham, William MD; Williams, Carolyn RN; Daya, Mohamud MD; Beeson, Jeff DO; McCully, Belinda H. PhD; Wheeler, Stephen MD; Kannas, Delores RN, MS, MHA; May, Susanne PhD; McKnight, Barbara PhD; Hoyt, David B. MD; the ROC Investigators

Journal of Trauma and Acute Care Surgery:
doi: 10.1097/TA.0000000000000600
AAST 2014 Plenary Papers
Abstract

BACKGROUND: Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients.

METHODS: Patients were enrolled and randomized in the out-of-hospital setting. Nineteen emergency medical services (EMS) systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood pressure (SBP) of 90 mm Hg or lower. CR patients received 250 mL of fluid if they had no radial pulse or an SBP lower than 70 mm Hg and additional 250-mL boluses to maintain a radial pulse or an SBP of 70 mm Hg or greater. The SR group patients received 2 L initially and additional fluid as needed to maintain an SBP of 110 mm Hg or greater. The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival.

RESULTS: A total of 192 patients were randomized (97 CR and 95 SR). The CR and SR groups were similar at baseline. The mean (SD) crystalloid volume administered during the study period was 1.0 L (1.5) in the CR group and 2.0 L (1.4) in the SR group, a difference of 1.0 L (95% confidence interval [CI], 0.6–1.4). Intensive care unit–free days, ventilator-free days, renal injury, and renal failure did not differ between the groups. At 24 hours after admission, there were 5 deaths (5%) in the CR group and 14 (15%) in the SR group (adjusted odds ratio, 0.39; 95% CI, 0.12–1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03–0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19–19.17).

CONCLUSION: CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted.

LEVEL OF EVIDENCE: Therapeutic study, level I.

Author Information

From the Department of Surgery, (M.A.S., B.H.M.), and Emergency Medicine, (C.D.N., MD.), Oregon Health & Science University, Portland, Oregon; Department of Biostatistics (E.N.M., S.M., B.M.), and Clinical Trial Center (D.K.), University of Washington, Seattle, Washington; Department of Surgery (S.A.T.), University of Maryland, Baltimore; and National Heart, Lung, and Blood Institute (D.E.), National Institutes of Health, Bethesda, Maryland; Department of Surgery (J.D.K., C.W.), University of Alabama at Birmingham, Birmingham, Alabama; Department of Surgery (K.B.), Medical College of Wisconsin, Milwaukee, Wisconsin; Trauma Surgery (W.W.), Texas Health Harris Methodist Hospital; and MedStar EMS, (J.B.), Fort Worth, Texas; American College of Surgeons (D.B.H.), Chicago, Illinois; and British Columbia Emergency Health Services (S.W.), Victoria, British Columbia, Canada.

Submitted: September 5, 2014, Revised: December 4, 2014, Accepted: January 12, 2015.

This study was presented at the 73rd annual meeting of the American Association for the Surgery of Trauma, September 9–13, 2014, in Philadelphia, Pennsylvania.

The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung and Blood Institute or the National Institutes of Health.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.jtrauma.com).

Address for reprints: Martin A. Schreiber, MD, Division of Trauma, Critical Care, and Acute Care Surgery, Department of Surgery, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, L-611; email: schreibm@ohsu.edu.

© 2015 Lippincott Williams & Wilkins, Inc.