Clinical Trial: Refractory Status Epilepticus Treatment Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.

Sponsor: Hospital Universitari de Bellvitge

Current Primary Outcome: status epilepticus resolution [ Time Frame: after 48h treatment administration ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT) [ Time Frame: During 48h post valproate administration ]

Original Secondary Outcome: Estimation of pharmacokinetic parameters of valporate (VPA) and phenitoine (PHT) [ Time Frame: During 48h post valproate administration ]

Information By: Hospital Universitari de Bellvitge

Dates:
Date Received: April 24, 2012
Date Started: January 2010
Date Completion:
Last Updated: March 10, 2013
Last Verified: March 2013