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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.
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰

KD Treatment for Super-refractory Status Epilepticus 84 식이 요법

모집중
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임상시험 NCT07496749 (KD)은(는) Super-refractory Status Epilepticus에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 10월 20일에 시작되어 84명의 참여자를 모집하고 있습니다. Xuanwu Hospital, Beijing이(가) 진행하며, 2027년 3월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
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).
상세한 설명

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:

  1. Control Group: Receives standard medical therapy according...
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공식 제목

Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial

질환명
Super-refractory Status Epilepticus
출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.
기타 연구 식별자
  • KD
  • KS2025230-001
NCT 번호
실제 연구 시작일
2025-10-20
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2027-03-01
계획된 등록 인원
84
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
ketogenic diet
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/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
주요결과변수
결과변수측정값 설명시간 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
참여 도우미
적격성 기준

연령대
어린이, 성인, 노인
최소 연령
14 Years
참여 가능한 성별
전체

(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

(1)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.(2)Intolerance to enteral feeding (e.g., intestinal obstruction);(3)Receipt of propofol infusion within 24 hours;(4)Hemodynamic instability (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg, requiring high-dose vasopressors for maintenance);(5)Liver failure (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], blood ammonia >5 times the upper limit of normal; total bilirubin >10 g/dL \[171 μmol/L\]);(6)Pancreatitis;(7)Pregnancy;(8)Metabolic instability (blood glucose <3.1 mmol/L, arterial blood pH <7.2, serum sodium <120 or >160 mmol/L);(9)Complicated by sepsis; (10)Complicated by diabetes insipidus;(11)Status epilepticus caused by hypoxic-ischemic brain injury.
Xuanwu Hospital, Beijing logoXuanwu Hospital, Beijing
연구 책임자
Weibi Chen, 책임연구자, Chief Physician and associate Professor, Xuanwu Hospital, Beijing
연구 대표 연락처
연락처: Weibi Chen, 0086-010-83198424, [email protected]
연락처: Gang Liu, 010-83198899, [email protected]
15 1개국에 임상시험 장소

Anhui

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China
Yajuan Hu, Dr, 연락처, 0086-0551-62922329, [email protected]
모집중

Beijing Municipality

Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, 100053, China
Weibi Chen, 연락처, 0086-010-83198899, [email protected]
모집중

Fujian

Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Shenggen Chen, 연락처, 0086-0591-83357896, [email protected]
모집중

Guangxi

The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Zhijian Liang, 연락처, 0086-0771-5322120, [email protected]
모집중

Guizhou

Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
Xiao Hu, 연락처, 0086-0851-85611278, [email protected]
모집중

Hainan

The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China
Pengxiang Li, 연락처, [email protected]
대상자모집전

Hebei

The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China
Jia Tian, 연락처, 0086-0311-87156771, [email protected]
모집중

Heilongjiang

The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
Linlin Sun, 연락처, [email protected]
모집중

Henan

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Wenjing Deng, 연락처, 0086-0371-66913114, [email protected]
대상자모집전

Neimenggu

Chifeng Municipal Hospital, Chifeng, Neimenggu, 024000, China
Huijie Zhou, 연락처, 0086-0476-8331476, [email protected]
모집중

Shandong

Qilu Hospital,Shandong University, Jinan, Shandong, 2500012, China
Qinzhou Wang, 연락처, 0086-0531-82166666, [email protected]
대상자모집전

Zhejiang

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, Zhejiang, 310009, China
Lida Su, 연락처, 0086-0571-87783777, [email protected]
모집중
Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China
Qinglin Yang, 연락처, 0086-010-58269911, [email protected]
대상자모집전
The First Hospital of Jilin University, Jilin, 130021, China
Jie Cao, 연락처, 0086-0431-84808243, [email protected]
모집중
Liaocheng People's Hospital, Liaocheng, 252000, China
Dong Guo, Dr, 연락처, 0086-13346252870, [email protected]
모집중