Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 14
研究概览
简要总结
The purpose of the study is to investigate to evaluate the efficacy and safety of ketogenic diet (KD) as an adjunctive therapy in patients with Super Refractory Status Epilepticus (SRSE) in the intensive care unit (ICU).
详细描述
This is a multicenter, prospective, randomized, controlled, open-label clinical study to evaluate the efficacy and safety of ketogenic diet (KD) as an adjunctive therapy in patients with Super Refractory Status Epilepticus (SRSE).
The study plans to enroll eligible SRSE patients. Participants will be randomly assigned in a 1:1 ratio to one of two groups:
- Control Group: Receives standard medical therapy according to current guideline recommendations for SRSE management.
- Intervention Group: Receives standard medical therapy plus a ketogenic diet intervention.
The KD intervention will be administered via a nasogastric tube using a ketogenic formula. The nutritional goal is 25-30 kcal/kg, initiated at half-strength and advanced to the full caloric target within 72 hours. If no clinical improvement is observed within 2 weeks of initiating the KD, it will be discontinued. For responders, continuation is recommended. All patients in the KD group will receive concomitant daily nutritional supplements.
The primary outcome measure is the efficacy of controlling SRSE within 2 weeks after randomization. Efficacy is defined as the cessation of both clinical and electrographic status epilepticus, as confirmed by continuous EEG monitoring.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with super-refractory status epilepticus (SRSE), in whom status epilepticus (SE) persists or recurs after the initial treatment for SE-including intravenous benzodiazepines, an anti-seizure medication (ASM, such as valproate, levetiracetam, or phenobarbital), and an anesthetic (e.g., propofol) administered continuously for 24 hours-fails to terminate the episode, or when SE recurs upon reduction of the anesthetic.
- •Age between 14 and 80 years, regardless of gender.
- •The patient's legal guardian has provided signed informed consent.
排除标准
- •Patients with lipid metabolism disorders, including defects in fatty acid transport and beta-oxidation, such as carnitine deficiency (primary) and carnitine-related enzyme deficiencies (including carnitine palmitoyltransferase [CPT] I and II deficiency, carnitine translocase deficiency), fatty acid oxidation disorders (including beta-oxidation defects), short-chain acyl-CoA dehydrogenase deficiency (SCAD), medium-chain acyl-CoA dehydrogenase deficiency (MCAD), long-chain acyl-CoA dehydrogenase deficiency (LCAD), long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, medium-chain 3-hydroxyacyl-CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, and porphyria.
- •Intolerance to enteral feeding (e.g., intestinal obstruction).
- •Receipt of propofol infusion within 24 hours.
- •Hemodynamic instability (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg, requiring high-dose vasopressors for maintenance).
- •Liver failure (aspartate aminotransferase [AST], alanine aminotransferase [ALT], blood ammonia >5 times the upper limit of normal; total bilirubin >10 mg/dL [171 μmol/L]).
- •Pancreatitis.
- •Pregnancy.
- •Metabolic instability (blood glucose <3.1 mmol/L, arterial blood pH <7.2, serum sodium <120 or >160 mmol/L).
- •Septic shock.
- •Complicated by diabetes insipidus.
- •Status epilepticus caused by hypoxic-ischemic brain injury.
研究组 & 干预措施
standard medical therapy for SRSE and KD therapy
the experimental arm is defined by the addition of the Ketogenic Diet to standard medical therapy
干预措施: the ketogenic diet (Other)
standard medical therapy for SRSE and KD therapy
the experimental arm is defined by the addition of the Ketogenic Diet to standard medical therapy
干预措施: Standard Medical Therapy (Drug)
standard care group
active comparator arm receives standard medical therapy alone.
干预措施: Standard Medical Therapy (Drug)
研究者
Weibi Chen
Chief Physician and associate Professor
Xuanwu Hospital, Beijing