title: Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial.
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.
  
  
  METHODS
  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].
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov, NCT00316017.
authors.affiliation: Department of Surgery, University of Washington, Seattle, WA, USA.ebulger@u.washington.edu
authors.forename: Eileen M
authors.initials: EM
authors.lastname: Bulger
authors.forename: Susanne
authors.initials: S
authors.lastname: May
authors.forename: Jeffery D
authors.initials: JD
authors.lastname: Kerby
authors.forename: Scott
authors.initials: S
authors.lastname: Emerson
authors.forename: Ian G
authors.initials: IG
authors.lastname: Stiell
authors.forename: Martin A
authors.initials: MA
authors.lastname: Schreiber
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Brasel
authors.forename: Samuel A
authors.initials: SA
authors.lastname: Tisherman
authors.forename: Raul
authors.initials: R
authors.lastname: Coimbra
authors.forename: Sandro
authors.initials: S
authors.lastname: Rizoli
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Minei
authors.forename: J Steven
authors.initials: JS
authors.lastname: Hata
authors.forename: George
authors.initials: G
authors.lastname: Sopko
authors.forename: David C
authors.initials: DC
authors.lastname: Evans
authors.forename: David B
authors.initials: DB
authors.lastname: Hoyt
mesh_terms: D000328:Adult; D001803:Blood Transfusion; D015331:Cohort Studies; D003131:Combined Modality Therapy; D003911:Dextrans / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D057239:Early Termination of Clinical Trials; D004632:Emergency Medical Services; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D006982:Hypertonic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012462:Saline Solution, Hypertonic / Q000008:administration & dosage* / Q000009:adverse effects; D012769:Shock / Q000401:mortality / Q000628:therapy*; D012774:Shock, Traumatic / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D055815:Young Adult
chemical_list: D003911:Dextrans; D006982:Hypertonic Solutions; D012462:Saline Solution, Hypertonic