A Randomized Clinical Trial for the Treatment of Refractory Status Epilepticus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- Refractory Status Epilepticus Controlled With First Course of Study Drug
研究概览
简要总结
The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.
详细描述
Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed.
The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia.
Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with refractory status epilepticus not due to cerebral anoxia, needing coma induction for clinical management.
排除标准
- •Age < 16 years old.
- •Known pregnancy.
- •Cerebral anoxia as SE etiology.
- •Epilepsia partialis continua (simple partial SE).
- •Known intolerance to the study drugs.
- •Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.
研究组 & 干预措施
1
propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
干预措施: propofol (Drug)
2
thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
干预措施: thiopental/pentobarbital (Drug)
结局指标
主要结局
Refractory Status Epilepticus Controlled With First Course of Study Drug
时间窗: after return of continuous EEG activity (typically after 36 hours - 5 days)
Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no)
次要结局
- Intubation Time in Survivors(Up to 3 months)
- Clinical Outcome at Day 21(21 days)
- Patients With Infectious Complications Requiring Specific Treatment(10 days)
- Patients With Hypotension Requiring Specific Treatment(10 days)
- Patients With Propofol Infusion Syndrome(10 days)
研究者
Andrea O. Rossetti, MD
Dr
Brigham and Women's Hospital