Status:
COMPLETED
Efficacy Study of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Generalized Convulsive Status Epilepticus
Intensive Care Unit
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study Hypothesis Generalized Convulsive Status Epilepticus (GCSE) is a medical emergency associated with an increased morbidity and a prolonged length of hospital stay. Only 50% of patients are discha...
Detailed Description
Patient admitted Intensive Care Unit (ICU) for a Generalized Convulsive Status Epilepticus (GCSE) will be randomized if they fulfil the inclusion criteria and after the written informed consent is obt...
Eligibility Criteria
Inclusion
- Patient older than 18.
- Admitted in a participating ICU for generalized convulsive status epilepticus (GCSE) i.e. with persistent or repeated generalized seizures without regaining consciousness over a period of five minutes. provided that the duration of the treatment prior antiepileptic does not exceed:
- Six hours if GCSE is already controlled at the time of inclusion (= disappearance seizures regardless of the state of consciousness)
- Twenty-four hours if GCSE persisted or is recurrent.
- Written informed consent collected from close relation or a family member of the patient. Otherwise, inclusion according to French Health Code in case of medical emergency. In this case, the written informed consent of patient has to be collected as soon as possible then. in absence of a close of patient, the patient may be still included. the consent of the prosecution will be collected
Exclusion
- Other type of status epilepticus (including atypical form) occured before the onset of anti epileptic.
- Female patient of childbearing age ≥ 18 ans et \< 50 ans
- Patient prior treated by depakine in emergency for the GCSE
- The length of stay in hospital expected before the occurrence of GCSE \> 15 days.
- Expected Length of stay in ICU \<12h .
- Hypoxic-ischemic encephalopathy.
- Pregnant women, eclampsia checked by a systematic pregnancy test.
- Pre-existing chronic or acute hepatitis, or Cirrhosis B or C.
- Family history of acute hepatitis, especially drug-related hepatitis
- Other sodium valproate Contraindications : Hypersensitivity to sodium valproate or derivatives, acute or chronic hepatitis; personal or family history of severe hepatitis, in particular drug; hepatic porphyria, mefloquine or hypericum taking.
- life expectancy expected ≤ 3 months.
- Patients already included in another clinical trial on GCSE.
- Non affiliation to a social health care.
- Patients under tutelage.
- Patient has already been included in this protocol and who completed the clinical trial.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT01791868
Start Date
February 1 2013
End Date
October 1 2018
Last Update
October 16 2018
Active Locations (1)
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1
Hôpital Raymond Poincare
Garche, Haute de Seine, France, 92380