Refractory Status Epilepticus Treatment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Grand Mal Status Epilepticus Non-convulsive Status Epilepticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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40mg/kg intial valproate bolus

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

Group Type ACTIVE_COMPARATOR

valproic acid (VPA)

Intervention Type DRUG

Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)

20mg/Kg intial bolus valproate

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

Group Type ACTIVE_COMPARATOR

valproic acid (VPA)

Intervention Type DRUG

Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)

Interventions

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valproic acid (VPA)

Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)

Intervention Type DRUG

Other Intervention Names

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Valrpoic acid Phenytoin Benzodiazepines Status Epilepticus Refractarius

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No