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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
5
Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
status epilepticus resolution
After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications
Time frame: after 48h treatment administration
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)
Time frame: During 48h post valproate administration
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