Clinical trial NCT01586208: Refractory Status Epilepticus Treatment Study
Official title: Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Grand Mal Status Epilepticus
Non-convulsive Status Epilepticus
Keywords: refractory status epilepticus
valproic acid
phenytoin
benzodiazepines
Valproic acid initial dosage in status treatment
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Germans Trias i Pujol Hospital
name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
name: Hospital Clinic of Barcelona
First posted: 2012-04-26
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: status epilepticus resolution
timeFrame: after 48h treatment administration
Secondary outcomes:
measure: Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)
timeFrame: During 48h post valproate administration
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Mercè Falip, MD
role: PRINCIPAL_INVESTIGATOR
References: