Stephane Legriel1, Virginie Lemiale1, Maleka Schenck1, Jonathan Chelly1, Virginie Laurent1, Fabrice Daviaud1, Mohamed Srairi1, Aicha Hamdi1, Guillaume Geri1, Thomas Rossignol1, Julia Hilly-Ginoux1, Julie Boisramé-Helms1, Benjamin Louart1, Isabelle Malissin1, Nicolas Mongardon1, Benjamin Planquette1, Marina Thirion1, Sybille Merceron1, Emmanuel Canet1, Fernando Pico1, Yves-Roger Tran-Dinh1, Jean-Pierre Bedos1, Elie Azoulay1, Matthieu Resche-Rigon1, Alain Cariou1. 1. From the Medical-Surgical Intensive Care Unit (S.L., V. Laurent, J.H.-G., B.P., S.M., J.-P.B.) and the Neurology and Stroke Department (F.P.), Centre Hospitalier de Versailles-Site André Mignot, Versailles, INSERM Unité 970 (Team 4), Paris Cardiovascular Research Center (S.L., A.C.), the Medical Intensive Care Unit (V. Lemiale, E.C., E.A.) and Department of Biostatistics and Medical Information (M.R.-R.), Saint Louis University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), the Medical Intensive Care Unit, Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP (F.D., G.G., N.M., A.C.), the Medical Intensive Care Unit (I.M.) and Neurophysiology Department (Y.-R.T.-D.), Lariboisière University Hospital, AP-HP, INSERM Unité 1153 (ECSTRA Team), Université Paris Diderot, Sorbonne Paris Cité (M.R.-R.), and Paris Descartes University, Sorbonne Paris Cité-Medical School (A.C.), Paris, the Medical Intensive Care Unit, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg (M. Schenck), and the Medical Intensive Care Unit, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, and Fédération de Médecine Translationnelle de Strasbourg, Faculté de Médecine, Université de Strasbourg (J.B.-H.), Strasbourg, the Medical-Surgical Intensive Care Unit, Centre Hospitalier de Melun, Melun (J.C.), the Anesthesiology and Critical Care Department, Toulouse University Hospital, University Toulouse 3 Paul Sabatier, Toulouse (M. Srairi), the Medical-Surgical Intensive Care Unit, Centre Hospitalier de Montreuil, Montreuil (A.H.), the Medical-Surgical Intensive Care Unit, Centre Hospitalier du Mans, Le Mans (T.R.), the Intensive Care Units, Division of Anesthesia, Intensive Care, Pain, and Emergency Medicine, University Hospital of Nîmes, Nîmes (B.L.), and the Medical-Surgical Intensive Care Unit, Centre Hospitalier Victor Dupouy, Argenteuil (M.T.) - all in France.
Abstract
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 receivingmechanical ventilation to hypothermia (32 to 34°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 .).
RCT Entities:
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°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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