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De klinische studie NCT07496749 (KD) voor Super-refractory Status Epilepticus is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
KD Treatment for Super-refractory Status Epilepticus 84 Dieet
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De klinische studie NCT07496749 (KD) is een interventioneel studie bij Super-refractory Status Epilepticus met de status rekruterend. Het doel is om 84 deelnemers te includeren vanaf 20 oktober 2025. De studie wordt geleid door Xuanwu Hospital, Beijing en de voltooiing is gepland op 1 maart 2027. Laatste update op ClinicalTrials.gov: 27 maart 2026.
Beknopte samenvatting
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).
Uitgebreide beschrijving
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...
Officiële titel
Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
Aandoeningen
Super-refractory Status EpilepticusPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- KD
- KS2025230-001
NCT-ID
Startdatum (Werkelijk)
2025-10-20
Laatste update geplaatst
2026-03-27
Verwachte einddatum
2027-03-01
Inschrijving (Geschat)
84
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
ketogenic diet
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Experimenteelstandard 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...Toon meer |
Actieve comparatorstandard 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...Toon meer |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
14 Years
Geslachten die in aanmerking komen voor de studie
Allen
(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, BeijingVerantwoordelijke instantie
Weibi Chen, Hoofdonderzoeker, Chief Physician and associate Professor, Xuanwu Hospital, Beijing
Centraal Contactpersoon
Contact: Weibi Chen, 0086-010-83198424, [email protected]
Contact: Gang Liu, 010-83198899, [email protected]
15 Studielocaties in 1 landen
Anhui
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China
Yajuan Hu, Dr, Contact, 0086-0551-62922329, [email protected]
Rekruterend
Beijing Municipality
Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, 100053, China
Weibi Chen, Contact, 0086-010-83198899, [email protected]
Rekruterend
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Shenggen Chen, Contact, 0086-0591-83357896, [email protected]
Rekruterend
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Zhijian Liang, Contact, 0086-0771-5322120, [email protected]
Rekruterend
Guizhou
Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
Xiao Hu, Contact, 0086-0851-85611278, [email protected]
Rekruterend
Hainan
The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China
Pengxiang Li, Contact, [email protected]
Nog niet rekruterend
Hebei
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China
Jia Tian, Contact, 0086-0311-87156771, [email protected]
Rekruterend
Heilongjiang
The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
Linlin Sun, Contact, [email protected]
Rekruterend
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Wenjing Deng, Contact, 0086-0371-66913114, [email protected]
Nog niet rekruterend
Neimenggu
Chifeng Municipal Hospital, Chifeng, Neimenggu, 024000, China
Huijie Zhou, Contact, 0086-0476-8331476, [email protected]
Rekruterend
Shandong
Qilu Hospital，Shandong University, Jinan, Shandong, 2500012, China
Qinzhou Wang, Contact, 0086-0531-82166666, [email protected]
Nog niet rekruterend
Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, Zhejiang, 310009, China
Lida Su, Contact, 0086-0571-87783777, [email protected]
Rekruterend
Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China
Qinglin Yang, Contact, 0086-010-58269911, [email protected]
Nog niet rekruterend
The First Hospital of Jilin University, Jilin, 130021, China
Jie Cao, Contact, 0086-0431-84808243, [email protected]
Rekruterend
Liaocheng People's Hospital, Liaocheng, 252000, China
Dong Guo, Dr, Contact, 0086-13346252870, [email protected]
Rekruterend