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Out-of-hospital Hypertonic Resuscitation After Traumatic Hypovolemic Shock: A Randomized, Placebo Controlled Trial

Bulger, Eileen M. MD*; May, Susanne PhD*; Kerby, Jeffery D. MD, PhD; Emerson, Scott MD, PhD*; Stiell, Ian G. MD; Schreiber, Martin A. MD§; Brasel, Karen J. MD, MPH; Tisherman, Samuel A. MD; Coimbra, Raul MD, PhD#; Rizoli, Sandro MD, PhD**; Minei, Joseph P. MD††; Hata, J. Steven MD‡‡; Sopko, George MD, MPH§; Evans, David C. MD‖‖; Hoyt, David B. MD for the ROC investigators¶¶

doi: 10.1097/SLA.0b013e3181fcdb22
Feature Article

Objective:   To determine whether out-of-hospital administration of hypertonic fluids would improve survival after severe injury with hemorrhagic shock.

Background:   Hypertonic fluids have potential benefit in the resuscitation of severely injured patients because of rapid restoration of tissue perfusion, with a smaller volume, and modulation of the inflammatory response, to reduce subsequent organ injury.

Methods:   Multicenter, randomized, blinded clinical trial, May 2006 to August 2008, 114 emergency medical services agencies in North America within the Resuscitation Outcomes Consortium. Inclusion criteria: injured patients, age ≥ 15 years with hypovolemic shock (systolic blood pressure ≤ 70 mm Hg or systolic blood pressure 71–90 mm Hg with heart rate ≥ 108 beats per minute). Initial resuscitation fluid, 250 mL of either 7.5% saline per 6% dextran 70 (hypertonic saline/dextran, HSD), 7.5% saline (hypertonic saline, HS), or 0.9% saline (normal saline, NS) administered by out-of-hospital providers. Primary outcome was 28-day survival. On the recommendation of the data and safety monitoring board, the study was stopped early (23% of proposed sample size) for futility and potential safety concern.

Results:   A total of 853 treated patients were enrolled, among whom 62% were with blunt trauma, 38% with penetrating. There was no difference in 28-day survival—HSD: 74.5% (0.1; 95% confidence interval [CI], −7.5 to 7.8); HS: 73.0% (−1.4; 95% CI, −8.7–6.0); and NS: 74.4%, P = 0.91. There was a higher mortality for the postrandomization subgroup of patients who did not receive blood transfusions in the first 24 hours, who received hypertonic fluids compared to NS [28-day mortality—HSD: 10% (5.2; 95% CI, 0.4–10.1); HS: 12.2% (7.4; 95% CI, 2.5–12.2); and NS: 4.8%, P < 0.01].

Conclusion:   Among injured patients with hypovolemic shock, initial resuscitation fluid treatment with either HS or HSD compared with NS, did not result in superior 28-day survival. However, interpretation of these findings is limited by the early stopping of the trial. Clinical Trial Registration: Clinical Trials.gov, NCT00316017

This is a randomized controlled trial of out-of-hospital resuscitation with hypertonic saline and hypertonic saline with dextran compared to normal saline in trauma patients with hypovolemic shock. There was no difference in the 28-day survival rate between treatment arms. The trial was closed early for futility and concerns regarding increased mortality in a post-randomization subgroup.

From the *Departments of Surgery and Biostatistics, University of Washington, Seattle; †University of Alabama at Birmingham Department of Surgery, Birmingham; ‡University of Ottawa Department of Emergency Medicine, Ottawa, Canada; §Oregon Health & Science University Department of Surgery, Portland; ‖Medical College of Wisconsin Department of Surgery, Milwaukee; ¶University of Pittsburgh Department of Surgery, Pittsburgh, PA; #University of California, San Diego Department of Surgery, San Diego; **University of Toronto Department of Surgery, Toronto, Ontario, Canada; ††University of Texas Southwestern Department of Surgery, Dallas; ‡‡University of Iowa, Iowa City; §§National Heart, Lung, and Blood Institute, NIH Bethesda, MD; ‖‖Vancouver General Hospital Department of Surgery, Vancouver, British Columbia, Canada; and ¶¶American College of Surgeons, Chicago, IL.

Reprints: Eileen M. Bulger, MD, Box 359796, Harborview Medical Center, 325, 9th Ave, Seattle, WA 98104. E-mail: ebulger@u.washington.edu.

The Resuscitation Outcome Consortium is supported by a series of cooperative agreements with 10 regional clinical centers and 1 data coordinating center (5U01 HL077863, HL077881, HL077871 HL077872, HL077866, HL077908, HL077867, HL077885, HL077887, HL077873, HL077865) from the National Heart, Lung and Blood Institute in partnership with the National Institute of Neurological Disorders and Stroke, US Army Medical Research & Material Command, The Canadian Institutes of Health Research—Institute of Circulatory and Respiratory Health, Defence Research and Development Canada, and the Heart and Stroke Foundation of Canada.

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