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Refractory Status Epilepticus Treatment Study

Primary Purpose

Grand Mal Status Epilepticus, Non-convulsive Status Epilepticus

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

valproic acid (VPA)

About this trial

This is an interventional treatment trial for Grand Mal Status Epilepticus focused on measuring refractory status epilepticus, valproic acid, phenytoin, benzodiazepines, Valproic acid initial dosage in status treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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.
Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case

Exclusion Criteria:

Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression.
Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises.
Patients < 18 years of age.
Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy).
Pregnant or breastfeeding.
Patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate
Patients with porphyria
Patients with severe liver disease or dysfunction.
Patients with heart block or second and third grade sinus bradycardia.

Sites / Locations

Hospital Universitari de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

40mg/kg intial valproate bolus

20mg/Kg intial bolus valproate

Arm Description

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

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

Outcomes

Primary Outcome Measures

status epilepticus resolution

After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications

Secondary Outcome Measures

Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)

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)

Full Information

NCT ID

NCT01586208

First Posted

April 24, 2012

Last Updated

March 10, 2013

Sponsor

Hospital Universitari de Bellvitge

Collaborators

Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT01586208

Brief Title

Refractory Status Epilepticus Treatment Study

Official Title

Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitari de Bellvitge

Collaborators

Hospital Vall d'Hebron, Germans Trias i Pujol Hospital, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta, Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Grand Mal Status Epilepticus, Non-convulsive Status Epilepticus

Keywords

refractory status epilepticus, valproic acid, phenytoin, benzodiazepines, Valproic acid initial dosage in status treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

40mg/kg intial valproate bolus

Arm Type

Active Comparator

Arm Description

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

Arm Title

20mg/Kg intial bolus valproate

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

valproic acid (VPA)

Other Intervention Name(s)

Valrpoic acid, Phenytoin, Benzodiazepines, Status Epilepticus Refractarius

Intervention Description

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

Primary Outcome Measure Information:

Title

status epilepticus resolution

Description

After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications

Time Frame

after 48h treatment administration

Secondary Outcome Measure Information:

Title

Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)

Description

Time Frame

During 48h post valproate administration

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case Exclusion Criteria: Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression. Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises. Patients < 18 years of age. Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy). Pregnant or breastfeeding. Patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate Patients with porphyria Patients with severe liver disease or dysfunction. Patients with heart block or second and third grade sinus bradycardia.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mercè Falip, MD

Organizational Affiliation

Hospital Universitari de Bellvitge

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari de Bellvitge

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

12. IPD Sharing Statement

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Refractory Status Epilepticus Treatment Study

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