Hypothermia for Neuroprotection in Convulsive Status Epilepticus.
Legriel, Stephane M.D.; Lemiale, Virginie M.D.; Schenck, Maleka M.D.; Chelly, Jonathan M.D.; Laurent, Virginie M.D.; Daviaud, Fabrice M.D.; Srairi, Mohamed M.D.; Hamdi, Aicha M.D.; Geri, Guillaume M.D., Ph.D.; Rossignol, Thomas M.D.; Hilly-Ginoux, Julia M.D.; Boisrame-Helms, Julie M.D.; Louart, Benjamin M.D.; Malissin, Isabelle M.D.; Mongardon, Nicolas M.D., Ph.D.; Planquette, Benjamin M.D., Ph.D.; Thirion, Marina M.D.; Merceron, Sybille M.D.; Canet, Emmanuel M.D., Ph.D.; Pico, Fernando M.D., Ph.D.; Tran-Dinh, Yves-Roger M.D., Ph.D.; Bedos, Jean-Pierre M.D., Ph.D.; Azoulay, Elie M.D., Ph.D.; Resche-Rigon, Matthieu M.D., Ph.D.; Cariou, Alain M.D., Ph.D.; the HYBERNATUS Study Group
[Article]
New England Journal of Medicine.
375(25):2457-2467, December 22, 2016.
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BACKGROUND: Convulsive status epilepticus often results in permanent neurologic impairment. We evaluated the effect of induced hypothermia on neurologic outcomes in patients with convulsive status epilepticus.
METHODS: In a multicenter trial, we randomly assigned 270 critically ill patients with convulsive status epilepticus who were receiving mechanical ventilation to hypothermia (32 to 34[degrees]C for 24 hours) in addition to standard care or to standard care alone; 268 patients were included in the analysis. The primary outcome was a good functional outcome at 90 days, defined as a Glasgow Outcome Scale (GOS) score of 5 (range, 1 to 5, with 1 representing death and 5 representing no or minimal neurologic deficit). The main secondary outcomes were mortality at 90 days, progression to electroencephalographically (EEG) confirmed status epilepticus, refractory status epilepticus on day 1, "super-refractory" status epilepticus (resistant to general anesthesia), and functional sequelae on day 90.
RESULTS: A GOS score of 5 occurred in 67 of 138 patients (49%) in the hypothermia group and in 56 of 130 (43%) in the control group (adjusted common odds ratio, 1.22; 95% confidence interval [CI], 0.75 to 1.99; P=0.43). The rate of progression to EEG-confirmed status epilepticus on the first day was lower in the hypothermia group than in the control group (11% vs. 22%; odds ratio, 0.40; 95% CI, 0.20 to 0.79; P=0.009), but there were no significant differences between groups in the other secondary outcomes. Adverse events were more frequent in the hypothermia group than in the control group.
CONCLUSIONS: In this trial, induced hypothermia added to standard care was not associated with significantly better 90-day outcomes than standard care alone in patients with convulsive status epilepticus. (Funded by the French Ministry of Health; HYBERNATUS ClinicalTrials.gov number, NCT01359332.)
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