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Refractory Status Epilepticus Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01586208
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : March 12, 2013
Sponsor:
Collaborators:
Hospital Vall d'Hebron
Germans Trias i Pujol Hospital
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Mercè Falip, Hospital Universitari de Bellvitge

Tracking Information
First Submitted Date  ICMJE April 24, 2012
First Posted Date  ICMJE April 26, 2012
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE January 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2013)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
Estimation of pharmacokinetic parameters of valporate (VPA) and phenitoine (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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Refractory Status Epilepticus Treatment Study
Official Title  ICMJE Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Grand Mal Status Epilepticus
  • Non-convulsive Status Epilepticus
Intervention  ICMJE Drug: valproic acid (VPA)
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
Study Arms  ICMJE
  • Active Comparator: 40mg/kg intial valproate bolus
    Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration
    Intervention: Drug: valproic acid (VPA)
  • Active Comparator: 20mg/Kg intial bolus valproate
    Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration
    Intervention: Drug: valproic acid (VPA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2013)
5
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2012)
10
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01586208
Other Study ID Numbers  ICMJE NEU-2009-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mercè Falip, Hospital Universitari de Bellvitge
Study Sponsor  ICMJE Hospital Universitari de Bellvitge
Collaborators  ICMJE
  • Hospital Vall d'Hebron
  • Germans Trias i Pujol Hospital
  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
  • Hospital Clinic of Barcelona
Investigators  ICMJE
Principal Investigator: Mercè Falip, MD Hospital Universitari de Bellvitge
PRS Account Hospital Universitari de Bellvitge
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP