Grand Mal Status Epilepticus, Non-convulsive Status Epilepticus
Conditions
Keywords
refractory status epilepticus, valproic acid, phenytoin, benzodiazepines, Valproic acid initial dosage in status treatment
Brief summary
Identify the most effective dose of valproic acid when used in combination with phenytoin for treatment of patients with refractory status epilepticus, which allow a better clinical course and prognosis of the disease.
Detailed description
Phase III Clinical trial, to identify the most effective dose of valproic acid (20mg/kg bolus, 1mg/kg/h maintenance vs 40mg/kg bolus, 2mg/kg/h maintenance) in combination with phenytoin, in patients with refractory status epilepticus. Multicenter clinical trial, single-blind, prospective, randomized 1:1 assignment.
Interventions
Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)
Sponsors
Hospital Vall d'Hebron
Germans Trias i Pujol Hospital
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 18 years of age who meet the diagnosis of EER seizure, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic): -Present seizures for at least 30 minutes without regaining awareness among them. 2. Patients ≥ 18 years of age who meet the diagnosis of nonconvulsive EER, and previously they have been treated according to the clinical protocol at our center status (Diazepam 10mg Clonazepam 1mg and Phenytoin or iv at a dose of 20mg/kg in case persistence of the clinic): * After submitting an EER seizures that yield clinically performed an EEG that shows SE electricity. * Evidence of a non-convulsive SE to perform an EEG of a patient admitted for any cause, either by filing seizures, altered mental status, or any other cause, and to persist after the treatment administered previously discussed. 3. Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case
Exclusion criteria
1. Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression. 2. Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises. 3. Patients \< 18 years of age. 4. Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy). 5. Pregnant or breastfeeding. 6. Patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate 7. Patients with porphyria 8. Patients with severe liver disease or dysfunction. 9. Patients with heart block or second and third grade sinus bradycardia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| status epilepticus resolution | after 48h treatment administration | After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT) | During 48h post valproate administration | Estimation of pharmacokinetic parameters of VPA (Cl: clearance, Vd: volume of distribution) and PHT (Vmax: maximum speed of metabolism and Km: plasma concentration at which the rate of metabolism is half the maximum) |
Countries
Spain
Outcome results
None listed