Evaluation of Therapeutic Hypothermia in Convulsive Status EPILEPTICUS in Adults in Intensive Care (HYBERNATUS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Interests of a Therapeutic Hypothermia Procedure in Convulsive Status EPILEPTICUS in Adults in Intensive Care - HYBERNATUS Study|
- Functional impairment at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Functional impairment is defined by a Glasgow Outcome Scale strictly less than 5.
The time of evaluation should be 3 months (+/- 1 month)
- mortality [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
- mortality [ Time Frame: ICU discharge ] [ Designated as safety issue: Yes ]
- mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- incidence of functional sequelae [ Time Frame: 3 months ] [ Designated as safety issue: No ]judged on the frequency of seizures, the recurrence of epileptic status after hospitalization, the number of anti-epileptic drug, mini mental score (MMS).
- length of icu stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Percentages of convulsive and non-convulsive seizure recurrences [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Percentages of convulsive and non-convulsive seizure [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Seizure duration in minutes [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Percentage of refractory status epilepticus cases [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Percentages of patients with 90-day functional sequelae [ Time Frame: 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Procedure: Moderate hypothermia
procedure of moderate hypothermia therapy, between 32 ° and 34 ° C for 24 hours
|No Intervention: control|
Status EPILEPTICUS (SE) is a major medical emergency. The incidence per 100,000 population has been estimated at 9.9 episodes in Europe and 41 episodes in the US. The overall morbidity and mortality associated with convulsive SE (CSE) is 60% at three months. The alteration of functional prognosis of these patients is more conventionally attributed to the cause than to CSE itself. Longer seizure duration, progression to refractory status EPILEPTICUS and presence of cerebral insult are strong factors independently associated with a poor functional outcome. These three factors offer may be amenable to improvement and hope for preventive strategies. Current guidelines recommend the use of anticonvulsant treatment whose goal is prompt cessation of clinical and electrical seizures. None of these treatments has demonstrated NEUROPROTECTICE property. Therapeutic moderate hypothermia (between 32 and 34 ° C) showed interest in neuroprotection of post anoxic coma patients after a cardiovascular arrest on ventricular fibrillation by reducing morbidity and mortality in about 20% without major side effects. This technique has been used successfully in various pathologies such as stroke or traumatic brain injury. Pathophysiological mechanisms involved in epileptogenesis and neurotoxicity induced by persistence of seizures can be blocked by therapeutic hypothermia. Recent work on experimental models of SE demonstrated neuroprotective and anticonvulsant interest of therapeutic hypothermia. Therapeutic hypothermia has also been successfully used in some cases of particularly refractory CSE. Its early use in patients with SE would have a double interest: neuroprotective and anticonvulsant. There is currently no published studies or ongoing to determine the interest of its early use in patients with CSE.
Thus, the current study AIMAS at evaluating the effectiveness of the implementation of a procedure of moderate hypothermia therapy, between 32 ° and 34 ° C for 24 hours, to reduce morbidity and mortality at 3 months (+ / - 1 week) in mechanically ventilated ICU patients with convulsive status EPILEPTICUS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359332
|Hôpital André MIGNOT- Service de réanimation médico-chirurgical|
|Le Chesnay, France, 78150|
|Principal Investigator:||Stéphane LEGRIEL, MD,||Assistance Publique - Hôpitaux de Paris|