Objectives: To evaluate the feasibility, safety and effectiveness of a new method of intravascular temperature management for inducing moderate hypothermia (MHT).
Design and settings: Prospective, international-multicenter clinical trial conducted in four university hospitals.
Patients: In a 2-year period 24 patients with severe head injury and refractory high ICP were treated with MHT (32.5 degrees C) by intravascular methods.
Results: Seventeen were males and seven females, with a median age of 25 years (range 15-60). The median Glasgow Coma Scale upon admission was 7 (range 3-13) and the median Injury Severity Score was 22 (range 13-43). A total of 75% of patients presented a diffuse lesion in the pre-enrollment computed tomography. Median time from injury until reaching refractory high ICP was 71.5 h after injury (minimum 14 h, maximum 251 h). Twelve patients (50%) reached this situation within the first 72 h after injury. MHT was attained in a median time of 3 h. Pre-enrollment median ICP was 23.8 mmHg and was reduced to 16.8 mmHg upon reaching target temperature. At 6 months after injury, nine patients had died (37.5%), six were severely disabled (25%), two moderately disabled (8.3%) and seven had a good recovery (29.2%). Of the nine patients who died, in four the cause was rebound ICP during rewarming, one death was attributed to accidental potassium overload, two to septic shock, one to cardiac arrest of unknown origin and the ninth to a pulmonary embolism.
Conclusion: Intravascular methods to induce MHT combined with precooling with cold saline at 4 degrees C appear to be feasible and effective in reducing ICP in patients with high ICP refractory to first-line therapeutic measures.