Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Vall d'Hebron | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | OTHER |
| Hospital Clinic of Barcelona |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40mg/kg intial valproate bolus | Active Comparator | Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration |
|
| 20mg/Kg intial bolus valproate | Active Comparator | Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valproic acid (VPA) | Drug | Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment) |
|
| Measure | Description | Time Frame |
|---|---|---|
| status epilepticus resolution | After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications | after 48h treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During 48h post valproate administration |
Not provided
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):
Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mercè Falip, MD | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
Not provided
| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| D010672 | Phenytoin |
| D001569 | Benzodiazepines |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |