This study was conducted by the Resuscitation Outcomes Consortium, a multicenter clinical trial network including 11 regional clinical centers in the United States and Canada. The trial involved 114 emergency medical services agencies within the catchment area served by the consortium.10 (link) Two trials with 2 distinct patient cohorts, one for hypovolemic shock and the other for TBI, were conducted simultaneously using the same intervention.
This report describes the outcome of the TBI cohort. This was a double-blind, 3-group, randomized controlled clinical trial comparing a 250-mL bolus of 7.5% saline (hypertonic saline) vs 7.5% saline/6% dextran 70 (hypertonic saline/dextran) vs 0.9% saline (normal saline) as the initial resuscitation fluid administered to injured patients with suspected severe TBI in the out-of-hospital setting. This dose of hypertonic saline and hypertonic saline/dextran was selected because it was the dose used in all previous prehospital trials and thus had a proven safety record. Previous studies suggested that the expected serum sodium level on admission would be 145 to 155 mEq/L. Details of the initial study design have been published.11 (link)
This report describes the outcome of the TBI cohort. This was a double-blind, 3-group, randomized controlled clinical trial comparing a 250-mL bolus of 7.5% saline (hypertonic saline) vs 7.5% saline/6% dextran 70 (hypertonic saline/dextran) vs 0.9% saline (normal saline) as the initial resuscitation fluid administered to injured patients with suspected severe TBI in the out-of-hospital setting. This dose of hypertonic saline and hypertonic saline/dextran was selected because it was the dose used in all previous prehospital trials and thus had a proven safety record. Previous studies suggested that the expected serum sodium level on admission would be 145 to 155 mEq/L. Details of the initial study design have been published.11 (link)
