임상 레이더 AI | ||
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임상시험 NCT07496749 (KD)은(는) Super-refractory Status Epilepticus에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
KD Treatment for Super-refractory Status Epilepticus 84 식이 요법
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...
Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
- KD
- KS2025230-001
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적standard medical therapy for SRSE and KD therapy the experimental arm is defined by the addition of the Ketogenic Diet to standard medical therapy | the ketogenic diet First, ketogenic formulation was initiated continuously via naso-enteric tube at 50% of goal and increase to goal (25-30 kcal/kg/day) within 72h. The KD regimen was continued according to seizure control and tolerance before discharge. If the patient was receiving oral nutrition, the modified MAD-KD regimen (carbohydrate 10-20 g/d) was initiated. In addition, if weaning off the diet after discharge, the reduction was...더 보기 |
활성 대조군standard care group active comparator arm receives standard medical therapy alone. | the ketogenic diet First, ketogenic formulation was initiated continuously via naso-enteric tube at 50% of goal and increase to goal (25-30 kcal/kg/day) within 72h. The KD regimen was continued according to seizure control and tolerance before discharge. If the patient was receiving oral nutrition, the modified MAD-KD regimen (carbohydrate 10-20 g/d) was initiated. In addition, if weaning off the diet after discharge, the reduction was...더 보기 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time to cessation of SRSE | Calculation Method: Based on electroencephalogram (EEG) and clinical seizure activity, the therapeutic efficacy is categorized into three levels:
Grade I (Seizure-free): Electrographic and clinical status epilepticus is completely controlled, and follow-up EEG shows resolution of electrographic status epilepticus; record the number of days required to achieve this.
Grade II (Partially effective): Epileptiform discharges are reduced by more than 50%; record the number of days required to achieve this.
Grade III (Ineffective): Epileptiform discharges are reduced by less than 50%; the recorded number of days required is 14 days. | 2 weeks |
(1) 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;(2) Age between 14 and 80 years, regardless of gender;(3) The patient's legal guardian has provided signed informed consent
Anhui
Beijing Municipality
Fujian
Guangxi
Guizhou
Hainan
Hebei
Heilongjiang
Henan
Neimenggu
Shandong
Zhejiang