Intensive Care Unit Clinical Trial
Official title:
Randomized and Multicenter Study Assessing the Efficacy of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.
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 discharged from the hospital within the first month after GCSE. Recent
Guidelines from Experts highlight the necessity to improve the efficiency of the first line
anti-epileptic (AE) therapy.
Intravenous Sodium Valproate (SV) might be an adjuvant AE drug to the recommended first line
AEs. Intravenous SV is available, well tolerated and easily injectible but also has
pharmacologic properties for reducing the risk of seizures relapses and for being
neuroprotective. However, efficacy of intravenous as an adjuvant therapy in GCSE has never
been properly assessed.
Primary Purpose The primary purpose is to assess if the association of intravenous Sodium
Valproate with the recommended treatment for Generalized Convulsive Status Epilepticus
increases to 20 % the number of living patients, discharged from the hospital at day 15.
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.
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