Resuscitation Outcomes Consortium (ROC) Hypertonic Saline with Dextran

From JEMS (the University of Iowa is part of this study):

The ROC consists of 10 resuscitation centers and one coordinating center. It's working on collaborative prehospital and early hospital clinical trials looking for instances of cardiopulmonary arrest and life-threatening trauma. Sponsors for this initiative include the National Heart, Lung and Blood Institute, the U.S. Department of Defense, the Canadian Institutes of Health Research, and other institutes within the National Institutes of Health.

In the fall of 2005, randomized control trials began to study clinical outcome in trauma patients in hypovolemic shock (BP 90) and severe brain injury (GCS 8). Patients have been randomized into three treatment groups:

1. 250 cc normal saline (0.9%);
2. 250 cc hypertonic saline (7.5%); and
3. 7.5% hypertonic saline with dextran (HSD, a synthetic colloid volume expander).

The inclusion criteria for the hypovolemic shock group are blunt or penetrating trauma, prehospital SBP 90 (about 30% loss of volume) and age 15 years (or weight > 50 kg if age is unknown).

Inclusion criteria for the traumatic brain injury group are blunt trauma, prehospital GCS 8 and prehospital SBP > 90 and age > 15 years or weight > 50 kg. Any patients who have both a GCS 8 and SBP 90 will be counted in the hypovolemic shock group but will have neurological outcome assessments.

The exclusion criteria for both groups are known or suspected pregnancies; age < 15 or weight < 50 kg; ongoing prehospital CPR; receipt of more than 2,000 cc of crystalloid, colloid or blood products; severe hypothermia, drowning or hangings; burns > 20% of TBSA in adults or 10% in children; isolated penetrating head trauma; and inability to gain IV access in the field.

The primary outcome measures are survival to discharge for the hypovolemic shock patients, and neurological outcome in the brain-injured patients.