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Journal of the American College of Surgeons, The

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Hypertonic Resuscitation: Design and Implementation of a Prehospital Intervention Trial - 01/11/17

Doi : 10.1016/j.jamcollsurg.2007.07.020 
Karen J. Brasel, MD, MPH, FACS a, ⁎, Eileen Bulger, MD, FACS b, Andrea J. Cook, PhD c, d, Laurie J. Morrison, MD, MSc, MPH e, Craig D. Newgard, MD, MPH f, Sam A. Tisherman, MD, FACS g, Jeffrey D. Kerby, MD, PhD, FACS h, Raul Coimbra, MD, PhD, FACS i, J. Steven Hata, MD, FCCP, MS j, David B. Hoyt, MD, FACS k

Resuscitation Outcomes Consortium Investigators

a Department of Surgery, Division of Trauma/Critical Care, Medical College of Wisconsin, Milwaukee, WI 
b Harborview Medical Center, University of Washington, Seattle, WA 
c Department of Biostatistics, University of Washington, Seattle, WA 
d Group Health Center for Health Studies, Seattle, WA 
e Sunnybrook Health Sciences Center, Department of Medicine, University of Toronto, Toronto, Ontario, Canada 
f Center for Policy and Research in Emergency Medicine, Department of Emergency Medicine, Oregon Health and Science University, Portland, OR 
g Department of Surgery, University of Pittsburgh, Pittsburgh, PA 
h Department of Surgery, the University of Alabama at Birmingham, Birmingham, AL 
i Division of Trauma, Surgical Critical Care, and Burns, University of California at San Diego School of Medicine, San Diego, CA 
j Division of Critical Care, Department of Anesthesia, University of Iowa, Iowa City, IA 
k Department of Surgery, University of California, Irvine, CA. 

Correspondence address: Karen J Brasel, MD, MPH, FACS, Department of Surgery, Division of Trauma/Critical Care, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI 53226.

Riassunto

Background

Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. Resuscitation with hypertonic saline (7.5%) solutions can reduce mortality in hypotensive and brain-injured patients.

Study Design

Two multicenter, randomized, clinical trials were designed to compare hypertonic saline resuscitation with or without dextran with conventional isotonic resuscitation in patients with hypovolemic shock or traumatic brain injury. During a 3-year period, 5,848 patients will be randomized, with a primary end point of 28-day survival in the hypovolemic shock cohort and 6-month neurologic outcomes in the traumatic brain injury cohort.

Results

This is a report of the study design and implementation of 2 large-scale prehospital intervention trials from the Resuscitation Outcomes Consortium that qualify for exception from informed consent required for emergency research outlined in FDA regulation 21CFR50.24 and the Canadian Tri-Council Agreement for research in emergency health situations (Article 2.8).

Conclusions

We have successfully designed and implemented two prehospital intervention trials. The proc-ess has helped define the numerous challenges that must be overcome to pursue exception from informed consent resuscitation research in the prehospital setting. The results of these studies will hopefully advance and improve the early care of the severely injured patient.

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations and Acronyms : EMS, GCS, GOSE, HS, HSD, IC, LAR, ROC, SBP, TBI


Mappa


 Competing Interests Declared: None.
This study was supported by a cooperative agreement (5U01 HL077863) with the National Heart, Lung and Blood Institute in partnership with the National Institute of Neurologic Disorders and Stroke, The Canadian Institutes of Health Research (CIHR)-Institute of Circulatory and Respiratory Health, Defense Research and Development Canada, and the Heart and Stroke Foundation of Canada.
All investigational drugs are technically “off label use” because the FDA has not provided indication for use. The Investigational New Drug application, filed with the FDA, is granted only if a drug is safe and the trial has scientific merit.


© 2008  American College of Surgeons. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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Vol 206 - N° 2

P. 220-232 - febbraio 2008 Ritorno al numero
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