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Completed

NCT Number: NCT01586208

Refractory Status Epilepticus Treatment Study

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Valproic Acid (VPA)

Drug

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

Other names: Valrpoic acid, Phenytoin, Benzodiazepines, Status Epilepticus Refractarius

Primary outcomes

  1. status epilepticus resolution

    Time frame: after 48h treatment administration

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

Secondary outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

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

Registry information

Official study title

Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 26, 2012
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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