Faculty Collaboration Database

Hypertonic resuscitation: design and implementation of a prehospital intervention trial. J Am Coll Surg 2008 Feb;206(2):220-32

Date

01/29/2008

Pubmed ID

18222373

DOI

10.1016/j.jamcollsurg.2007.07.020

Scopus ID

2-s2.0-38349112004 (requires institutional sign-in at Scopus site)   60 Citations

Abstract

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.

Author List

Brasel KJ, Bulger E, Cook AJ, Morrison LJ, Newgard CD, Tisherman SA, Kerby JD, Coimbra R, Hata JS, Hoyt DB, Resuscitation Outcomes Consortium Investigators

MESH terms used to index this publication - Major topics in bold

Brain Injuries
Dextrans
Emergency Medical Services
Humans
Randomized Controlled Trials as Topic
Research Design
Saline Solution, Hypertonic
Shock, Traumatic
Sodium Chloride