Refractory Status Epilepticus Treatment Study

Catalan Institute of Health

Status and phase: Completed; Phase 3

Conditions: Grand Mal Status Epilepticus; Non-convulsive Status Epilepticus

Treatments: Drug: valproic acid (VPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01586208

NEU-2009-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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5 participants in 2 patient groups

40mg/kg intial valproate bolus

Active Comparator group

Description:

Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration

Treatment:

Drug: valproic acid (VPA)

20mg/Kg intial bolus valproate

Active Comparator group

Description:

Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration

Treatment:

Drug: valproic acid (VPA)