A multicenter prospective randomized controlled trial of the efficacy of mild hypothermia for severely head injured patients with low intracranial pressure

Object. The criteria for the use of mild hypothermia (34 degreesC) in sever ely head injured patients have not been standardized. A prospective randomi zed controlled trial was conducted to determine whether mild hypothermia is essential in the treatment of severely head injured patients with low intr acranial pressure (ICP). Methods. At 11 medical centers, 91 severely head injured patients with an a dmission Glasgow Coma Scale score of 8 or less in whom ICP could be maintai ned below 25 mm Hg by conventional therapies were divided randomly into two groups: the mild hypothermia group (HT group, 45 patients) and the normoth ermia group (NT group, 46 patients). Patients in the HT group were exposed to mild hypothermia (34 degreesC) for 48 hours, followed by rewarming at 1 degreesC per day for 3 days. whereas patients in the NT group were exposed to normothermia (37 degreesC) for 5 days. The two groups were similar with respect to prognostic factors, and there was no difference in clinical outc ome at 3 months postinjury. During treatment, there was a significantly gre ater use of neuromuscular blocking agents in the HT group (p = 0.011). Duri ng the initial 2 weeks postinjury, the incidences of pneumonia, meningitis, leukocytopenia, thrombocytopenia, hypernatremia, hypokalemia, and hyperamy lasemia were significantly higher in the HT than in the NT group (p < 0.05) . Conclusions. Mild hypothermia should not be used for the treatment of sever ely head injured patients with low ICP because this therapy conveys no adva ntage over normothermia in such patients.