Therapeutic hypothermia in patients with acute large hemispheric infarction: a randomized controlled clinical trial

Abstract

Objective To investigate the clinical effects of therapeutic hypothermia on the mortality and neurological function recovery in patients with acute large hemispheric infarction(LHI). Methods Seventy-three acute LHI patients (within 24 hours of symptom onset) admitted to our hospital from February 2015 to July 2016 were randomized to the hypothermia group (37 patients)and the control group (36 patients). Patients in the hypothermia group were given standard medical treatment and the surface cooling with a target temperature between 32-35 ℃ lasting for 5-7 days. Patients in the control group were given standard medical treatment and maintained a target temperature of normothermia. All patients were observed the primary end points including mortality and the modified Rankin Scale (mRS) score at 3 months. Results At three months, nine patients of survivors in the hypothermia group had good outcome (mRS score 0-3), whereas only five patients of survivors in the control group, though there was no significant difference (9/17 vs 5/19, χ2=2.676, P>0.05)between the two groups. Twenty patients (54.1%)died in the hypothermia group , while 17 patients(47.2%) in the control group(χ2=0.341, P>0.05). Conclusion Therapeutic hypothermia is safe and feasible to patients with acute LHI, but may neither reduce mortality nor improve the neurological outcome in survivors. Key words: Hypothermia; Stroke; Cerebral infarction; Prognosis