Trial Radar KI | ||
|---|---|---|
Die klinische Studie NCT07496749 (KD) für Super-refractory Status Epilepticus ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
KD Treatment for Super-refractory Status Epilepticus 84 Ernährung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07496749 (KD) ist eine interventionsstudie zur Untersuchung von Super-refractory Status Epilepticus und hat den Status offene rekrutierung. Die Studie startete am 20. Oktober 2025 und soll 84 Teilnehmer aufnehmen. Durchgeführt von Xuanwu Hospital, Beijing ist der Abschluss für 1. März 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
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).
Ausführliche Beschreibung
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...
Offizieller Titel
Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
Erkrankungen
Super-refractory Status EpilepticusPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- KD
- KS2025230-001
NCT-Nummer
Studienbeginn (tatsächlich)
2025-10-20
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2027-03-01
Geplante Rekrutierung
84
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
ketogenic diet
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Experimentellstandard 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...Mehr anzeigen |
Aktives Vergleichspräparatstandard 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...Mehr anzeigen |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
14 Years
Zugelassene Geschlechter
Alle
(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, BeijingVerantwortliche Partei
Weibi Chen, Hauptprüfer, Chief Physician and associate Professor, Xuanwu Hospital, Beijing
Zentrale Studienkontakte
Kontakt: Weibi Chen, 0086-010-83198424, [email protected]
Kontakt: Gang Liu, 010-83198899, [email protected]
15 Studienstandorte in 1 Ländern
Anhui
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China
Yajuan Hu, Dr, Kontakt, 0086-0551-62922329, [email protected]
Offene Rekrutierung
Beijing Municipality
Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, 100053, China
Weibi Chen, Kontakt, 0086-010-83198899, [email protected]
Offene Rekrutierung
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Shenggen Chen, Kontakt, 0086-0591-83357896, [email protected]
Offene Rekrutierung
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Zhijian Liang, Kontakt, 0086-0771-5322120, [email protected]
Offene Rekrutierung
Guizhou
Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
Xiao Hu, Kontakt, 0086-0851-85611278, [email protected]
Offene Rekrutierung
Hainan
The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China
Pengxiang Li, Kontakt, [email protected]
Noch nicht rekrutierend
Hebei
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China
Jia Tian, Kontakt, 0086-0311-87156771, [email protected]
Offene Rekrutierung
Heilongjiang
The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
Linlin Sun, Kontakt, [email protected]
Offene Rekrutierung
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Wenjing Deng, Kontakt, 0086-0371-66913114, [email protected]
Noch nicht rekrutierend
Neimenggu
Chifeng Municipal Hospital, Chifeng, Neimenggu, 024000, China
Huijie Zhou, Kontakt, 0086-0476-8331476, [email protected]
Offene Rekrutierung
Shandong
Qilu Hospital，Shandong University, Jinan, Shandong, 2500012, China
Qinzhou Wang, Kontakt, 0086-0531-82166666, [email protected]
Noch nicht rekrutierend
Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, Zhejiang, 310009, China
Lida Su, Kontakt, 0086-0571-87783777, [email protected]
Offene Rekrutierung
Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China
Qinglin Yang, Kontakt, 0086-010-58269911, [email protected]
Noch nicht rekrutierend
The First Hospital of Jilin University, Jilin, 130021, China
Jie Cao, Kontakt, 0086-0431-84808243, [email protected]
Offene Rekrutierung
Liaocheng People's Hospital, Liaocheng, 252000, China
Dong Guo, Dr, Kontakt, 0086-13346252870, [email protected]
Offene Rekrutierung