VALSERandomized and Multicenter Study Assessing the Efficacy of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.
Intravenous Sodium Valproate
+ Placebo
Brain Diseases+6
+ Central Nervous System Diseases
+ Nervous System Diseases
Treatment Study
Summary
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.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 obtained from the patient's next of kin. In clack of closed relatives, patients could be included according to the French Health Code for Case of medical emergency. In this situation, patient's consent should be then obtained as soon as possible According to randomization arm, patients will be treated either by intravenous sodium valproate (30 mg/kg during 15 min then 1 mg/kg/h during 12 h) or intravenous placebo. All included patients will benefit from first-line anti epileptic drugs and symptomatic medical care, in agreement with the Experts recommendation (RFE 2009). From day-1 to day-15, level consciousness(Glasgow Coma Scale, Richmond Agitation Sedation Scale), delirium (Confusion Assessment Method For Intensive Care Unit), reoccurrence of seizure, vital signs, organ dysfunction (Simplified Acute Physiology Score II, Sequential Organ Failure) will be daily assessed. At day 2, the preventive oral anti-epileptic drug will be prescribed by a neurologist, blinded from randomization. At Day 15 and Day 30, neurological status, cognitive functions (Mini Mental State Examination, Frontal Assessment Battery, Glasgow Outcome Scale), and quality of life (SF36) will be assessed by a neurologist, also not aware of the randomization. The number of patients alive and discharged from Hospital day 15 15th day will assessed. 300 patients with GCSE will be randomized, 150 in each arm, in 16 ICUs and over a period of 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.245 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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 Criteria: 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location