VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Primary Pharmacologic Outcome - Absorption
研究概览
简要总结
This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.
详细描述
This pilot trial aims to demonstrate the feasibility of enteral administration of a single load of vigabatrin within targeted 48 hours of post-anoxic status epilepticus onset in unconscious survivors of cardiac arrest undergoing targeted temperature management. The load of VGB is in addition to the load of a commonly used intravenous second-line therapy given at the discretion of the treating neurologist. Serial blood tests will be obtained, including vigabatrin levels, taurine levels, neuron specific enolase, light chain neurofilament, and glial fibrillary acidic protein. In survivors that regain consciousness and survive to follow up, 6 months visual field perimetry will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants are unconscious, thus, inherently blinded to the intervention. All the endpoints are objective and will be assessed by a blinded investigator to the timing of vigabatrin administration.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •non-traumatic cardiac arrest (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic status epilepticus (as defined by the American Clinical Neurophysiology Society: having generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching > 4Hz, lasting ≥ 10 minutes, or comprising > 50% of any hour of recording) has been made
- •requiring anesthetic infusion for any reason
- •have reliable arterial access for frequent blood sampling
- •established enteral access within 48h of post-anoxic status epilepticus onset.
排除标准
- •prior history of generalized epilepsy
- •history of gastrointestinal surgery within the last 21 days
- •pregnancy
- •status epilepticus onset preceding initiation of electroencephalography monitoring
研究组 & 干预措施
Open label
4500 mg of vigabatrin administered enterally
干预措施: Vigabatrin Only Product (Drug)
结局指标
主要结局
Primary Pharmacologic Outcome - Absorption
时间窗: 3h
By analyzing serial vigabatrin levels including baseline, we characterized vigabatrin absorption; the target was to achieve a detectable vigabatrin level in the serum of ≥ 80% of enrolled subjects by 3 hours post-load.
Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry)
时间窗: 6 months
We planned to obtain Goldmann perimetry testing in the subjects who could cooperate at the 6 months follow-up. Our goal was to have reliable visual field perimetry in ≥ 80% of survivors who regained consciousness following index hospitalization.
Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels
时间窗: 0h, 72h and 168h following vigabatrin administration
We obtained serial taurine levels during ICU stay at time 0h, 72h and 168h following vigabatrin administration. Our goal was to achieve a 90% completion rate for taurine levels.
Primary Feasibility Outcome - Enrollment and Drug Delivery
时间窗: 48 hours
We looked at the ability to deliver vigabatrin within 48 hours of PASE onset in ≥ 80% of enrolled subjects. Vigabatrin dose was adjusted according to renal functioning (CrCl\>50 ml/min: 4500 mg, CrCl 30-50 ml/min: 2250 mg, CrCl\<30 ml/min: 1125 mg)
次要结局
- Secondary Pharmacologic Outcome: Elimination(72h and 7 days following vigabatrin administration)
- Ultra-early Vigabatrin Administration(0h to 48h after vigabatrin admnistration)
- PASE Onset Detection(Determined at the time of connection to EEG monitoring)