NCT01796574已完成不适用
Feasibility and Tolerability of the Ketogenic Diet in the Treatment of Refractory Status Epilepticus in a Neurointensive Care Unit.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 16
- 主要终点
- Feasibility
研究概览
简要总结
This research is being done to observe the safety, tolerability, side effects, and effectiveness of the ketogenic diet in people with continuous seizures (status epilepticus) being treated in a neurointensive care unit.
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
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
- •Patients 18 years and older in refractory status epilepticus (continuous or recurrent seizures without return to baseline mental status between seizures, lasting > 30 minutes) placed on anesthetics/sedating agents (barbiturates or benzodiazepines) after at least one first- and second-line agent failed to control seizures, and with clinical and/or electrographic seizures following attempt to wean anesthetic/sedating agents after 24 hours.
排除标准
- •Unstable metabolic condition
- •Hemodynamic or cardiorespiratory instability
- •Coagulopathy
- •Liver failure
- •Total cholesterol > 300 mg/dL
- •Inability to tolerate enteral feeds, including ileus
- •Family refusal/no consent
- •Received any propofol infusions within 24 hours
- •Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
结局指标
主要结局
Feasibility
时间窗: 2 weeks
Whether or not the diet protocol was followed
次要结局
- Time to achieving serum and/or urinary ketosis(Until serum or urinary ketosis is achieved, an expected average of 2 weeks)
- Time to seizure reduction(Participants will be followed for the duration of the hospital stay, an expected average of 6 weeks)
- Ranking of tolerability measures on a 10 point scale(6 months)
- Number of participants with adverse events and description of events(6 months)
研究者
Mackenzie Cervenka
Assistant Professor of Neurology
Johns Hopkins University
研究点 (16)
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