Evaluation of Therapeutic Hypothermia in Convulsive Status EPILEPTICUS in Adults in Intensive Care (HYBERNATUS)
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|ClinicalTrials.gov Identifier: NCT01359332|
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Convulsive Status EPILEPTICUS||Procedure: Moderate hypothermia||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Interests of a Therapeutic Hypothermia Procedure in Convulsive Status EPILEPTICUS in Adults in Intensive Care - HYBERNATUS Study|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Procedure: Moderate hypothermia
procedure of moderate hypothermia therapy, between 32 ° and 34 ° C for 24 hours
|No Intervention: control|
- Functional impairment at 3 months [ Time Frame: 3 months ]
Functional impairment is defined by a Glasgow Outcome Scale strictly less than 5.
The time of evaluation should be 3 months (+/- 1 week)
- mortality [ Time Frame: hospital discharge ]
- mortality [ Time Frame: ICU discharge ]
- mortality [ Time Frame: 90 days ]
- Incidence of functional sequelae [ Time Frame: 3 months ]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 ]
- length of hospital stay [ Time Frame: 3 months ]
- Percentages of convulsive and non-convulsive seizure recurrences [ Time Frame: 6 to 12 hours ]Progression to status epilepticus
- Seizure duration in minutes [ Time Frame: 3 days ]
- Percentage of refractory status epilepticus cases [ Time Frame: 3 days ]Judged on the frequency of seizures within 24 hours after status epilepticus onset (refractory status epilepticus on day 1) and on the frequency of seizures within 48 hours after anesthetic treatment withdrawal (super refractory status epilepticus)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359332
|Hôpital André MIGNOT- Service de réanimation médico-chirurgical|
|Le Chesnay, France, 78150|
|Principal Investigator:||Stéphane LEGRIEL, MD,||Assistance Publique - Hôpitaux de Paris|