Adding hypothermia therapy to standard care for convulsive status epilepticus is not neuroprotective, according to a report published online Dec. 22 in the New England Journal of Medicine.
Small-animal studies recently reported that therapeutic hypothermia had antiepileptic and neuroprotective properties. Researchers performed an open-label, randomized controlled trial to examine whether the treatment would improve neurologic outcomes in 268 consecutive adults treated at 11 ICUs in France for convulsive status epilepticus during a 4-year period. The average patient age was 57 years, and approximately half the study participants had a history of epilepsy. All required mechanical ventilation.
A total of 130 patients were assigned to receive standard care, and 138 were assigned to hypothermia in which their core body temperature was rapidly lowered to 32-34 degrees C and maintained at that level for 24 hours. Hypothermia was induced using ice-cold IV fluids and was maintained by applying ice packs to the groin and neck and surrounding the patient in a cold-air tunnel, said Stephane Legriel, MD, of the Medical-Surgical ICU, Centre Hospitalier de Versailles-Site André Mignot, France, and his associates.
The primary outcome measure – the absence of functional impairment 90 days after admission, defined as a score of 5 on the Glasgow Outcome Scale – occurred in 49% of the hypothermia group and 43% of the control group, indicating that the addition of hypothermia was not neuroprotective. In addition, ICU mortality, in-hospital mortality, and 90-day mortality were not significantly different between the two study groups. More patients in the hypothermia group (51%) than in the standard-care group (45%) developed pneumonia that was attributed to aspiration, the investigators reported (N Engl J Med. 2016;375:2457-67).
“The results of this trial do not support a beneficial effect of therapeutic hypothermia as compared with standard care alone in patients with convulsive status epilepticus receiving mechanical ventilation,” Dr. Legriel and his associates wrote.
This study was supported by the French Ministry of Health and received no industry support or involvement. Dr. Legriel reported having no relevant financial disclosures; two of his associates reported ties to Alexion, Astellas, Bard, and Gilead.