Convulsive Status EPILEPTICUS Clinical Trial
Official title:
Evaluation of the Interests of a Therapeutic Hypothermia Procedure in Convulsive Status EPILEPTICUS in Adults in Intensive Care - HYBERNATUS Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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