title: A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.
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).
  
  
  CONCLUSIONS
  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.
  
  
  METHODS
  Therapeutic study, level I.
authors: 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.
authors: Martin A
authors: MA
authors: Schreiber
authors: Eric N
authors: EN
authors: Meier
authors: Samuel A
authors: SA
authors: Tisherman
authors: Jeffrey D
authors: JD
authors: Kerby
authors: Craig D
authors: CD
authors: Newgard
authors: Karen
authors: K
authors: Brasel
authors: Debra
authors: D
authors: Egan
authors: William
authors: W
authors: Witham
authors: Carolyn
authors: C
authors: Williams
authors: Mohamud
authors: M
authors: Daya
authors: Jeff
authors: J
authors: Beeson
authors: Belinda H
authors: BH
authors: McCully
authors: Stephen
authors: S
authors: Wheeler
authors: Delores
authors: D
authors: Kannas
authors: Susanne
authors: S
authors: May
authors: Barbara
authors: B
authors: McKnight
authors: David B
authors: DB
authors: Hoyt
mesh_terms: D000328:Adult; D002170:Canada; D000077324:Crystalloid Solutions; D005240:Feasibility Studies; D005260:Female; D005440:Fluid Therapy / Q000379:methods; D006801:Humans; D007022:Hypotension / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007552:Isotonic Solutions / Q000627:therapeutic use; D008297:Male; D009104:Multiple Trauma / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D061214:Patient Safety; D011446:Prospective Studies; D012151:Resuscitation / Q000379:methods*; D016896:Treatment Outcome; D014481:United States
chemical_list: D000077324:Crystalloid Solutions; D007552:Isotonic Solutions