Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
NCT Number: NCT01586208
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.
Looking for future studies?
Notify MeAll sexes
Interventional
Phase 3
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Present seizures for at least 30 minutes without regaining awareness among them.
Exclusion criteria
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
Time frame: after 48h treatment administration
After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications
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)
Hospital Universitari de Bellvitge
Other
Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
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.
Published trials that share one or more normalized conditions with this study.
NCT02920060
Grand Mal Status Epilepticus, Nervous System Diseases
View Trial DetailsNCT05418634
Altered Mental Status, Nervous System Diseases
Zurich, Switzerland
View Trial DetailsNCT05263674
Nervous System Diseases, Neurologic Manifestations
Aarhus, Denmark
View Trial DetailsNCT05756621
Cardiac Arrest, Cardiovascular Diseases
Brescia, BS, Italy
View Trial Details