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Annals of Surgery:
doi: 10.1097/SLA.0b013e3181fcdb22
Feature Article

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¶¶

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Abstract

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

© 2011 Lippincott Williams & Wilkins, Inc.

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