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L'essai clinique NCT07496749 (KD) pour Super-refractory Status Epilepticus est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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KD Treatment for Super-refractory Status Epilepticus 84 Diététique
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L'essai clinique NCT07496749 (KD) est une étude interventionnel pour Super-refractory Status Epilepticus. Son statut actuel est : en recrutement. L'étude a débuté le 20 octobre 2025 et vise à recruter 84 participants. Dirigée par Xuanwu Hospital, Beijing, l'étude devrait être terminée d'ici le 1 mars 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 mars 2026.
Résumé succinct
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).
Description détaillée
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...
Titre officiel
Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
Pathologies
Super-refractory Status EpilepticusPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:Autres identifiants de l'étude
- KD
- KS2025230-001
Numéro NCT
Date de début (réel)
2025-10-20
Dernière mise à jour publiée
2026-03-27
Date de fin (estimée)
2027-03-01
Inscription (estimée)
84
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
ketogenic diet
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Expérimentalstandard 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...Afficher plus |
Comparateur actifstandard 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...Afficher plus |
Critère principal d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
14 Years
Sexes éligibles
Tous
(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, BeijingPartie responsable de l'étude
Weibi Chen, Investigateur principal, Chief Physician and associate Professor, Xuanwu Hospital, Beijing
Contact central de l'étude
Contact: Weibi Chen, 0086-010-83198424, [email protected]
Contact: Gang Liu, 010-83198899, [email protected]
15 Centres de l'étude dans 1 pays
Anhui
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China
Yajuan Hu, Dr, Contact, 0086-0551-62922329, [email protected]
En recrutement
Beijing Municipality
Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, 100053, China
Weibi Chen, Contact, 0086-010-83198899, [email protected]
En recrutement
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Shenggen Chen, Contact, 0086-0591-83357896, [email protected]
En recrutement
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Zhijian Liang, Contact, 0086-0771-5322120, [email protected]
En recrutement
Guizhou
Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
Xiao Hu, Contact, 0086-0851-85611278, [email protected]
En recrutement
Hainan
The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China
Pengxiang Li, Contact, [email protected]
Pas encore en recrutement
Hebei
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China
Jia Tian, Contact, 0086-0311-87156771, [email protected]
En recrutement
Heilongjiang
The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
Linlin Sun, Contact, [email protected]
En recrutement
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Wenjing Deng, Contact, 0086-0371-66913114, [email protected]
Pas encore en recrutement
Neimenggu
Chifeng Municipal Hospital, Chifeng, Neimenggu, 024000, China
Huijie Zhou, Contact, 0086-0476-8331476, [email protected]
En recrutement
Shandong
Qilu Hospital，Shandong University, Jinan, Shandong, 2500012, China
Qinzhou Wang, Contact, 0086-0531-82166666, [email protected]
Pas encore en recrutement
Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, Zhejiang, 310009, China
Lida Su, Contact, 0086-0571-87783777, [email protected]
En recrutement
Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China
Qinglin Yang, Contact, 0086-010-58269911, [email protected]
Pas encore en recrutement
The First Hospital of Jilin University, Jilin, 130021, China
Jie Cao, Contact, 0086-0431-84808243, [email protected]
En recrutement
Liaocheng People's Hospital, Liaocheng, 252000, China
Dong Guo, Dr, Contact, 0086-13346252870, [email protected]
En recrutement