Refractory Status Epilepticus: Plasmatic Levels Monitorization Utility
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- status epilepticus resolution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •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.
- •Patients in whom it has obtained the written informed consent by the representative and/or patient, as the case
排除标准
- •Patients with severe cerebral anoxia, when the first EEG evidences a pattern of flare-suppression.
- •Patients who registers PLEDs (periodic epileptic lateralaized Discharges) without clinical seizure activity association to register or without electrical crises.
- •Patients < 18 years of age.
- •Patients in whom there is diagnostic doubt (eg non-convulsive status among and encephalopathy).
- •Pregnant or breastfeeding.
- •Patients with allergy to phenytoin, hydantoin or hypersensitivity to sodium valproate
- •Patients with porphyria
- •Patients with severe liver disease or dysfunction.
- •Patients with heart block or second and third grade sinus bradycardia.
研究组 & 干预措施
40mg/kg intial valproate bolus
Patient receives a 40mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration
干预措施: valproic acid (VPA) (Drug)
20mg/Kg intial bolus valproate
Patient receives a 20mg/kg valproate bolus with a maintenance of 1mg/kg/h, after benzodiazepine + phenytoin administration
干预措施: valproic acid (VPA) (Drug)
结局指标
主要结局
status epilepticus resolution
时间窗: after 48h treatment administration
After 48h treatment administration the status epilepticus has to be solved without any other antiepileptic medications
次要结局
- Estimation of pharmacokinetic parameters of valproate (VPA) and phenytoin (PHT)(During 48h post valproate administration)
研究者
Mercè Falip
MD
Hospital Universitari de Bellvitge