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Lo studio clinico NCT07496749 (KD) per Super-refractory Status Epilepticus è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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KD Treatment for Super-refractory Status Epilepticus 84 Dieta
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La sperimentazione clinica NCT07496749 (KD) è uno studio interventistico per Super-refractory Status Epilepticus, attualmente in arruolamento. Avviato il 20 ottobre 2025, prevede di arruolare 84 partecipanti. Sotto la guida di Xuanwu Hospital, Beijing, dovrebbe concludersi entro il 1 marzo 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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).
Descrizione dettagliata
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...
Titolo ufficiale
Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
Patologie
Super-refractory Status EpilepticusPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- KD
- KS2025230-001
Numero NCT
Data di inizio (effettiva)
2025-10-20
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-03-01
Arruolamento (previsto)
84
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
ketogenic diet
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Sperimentalestandard 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...Mostra di più |
Comparatore attivostandard 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...Mostra di più |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
14 Years
Sessi idonei
Tutti
(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, BeijingParte responsabile dello studio
Weibi Chen, Investigatore principale, Chief Physician and associate Professor, Xuanwu Hospital, Beijing
Contatti principali dello studio
Contatto: Weibi Chen, 0086-010-83198424, [email protected]
Contatto: Gang Liu, 010-83198899, [email protected]
15 Centri dello studio in 1 paesi
Anhui
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China
Yajuan Hu, Dr, Contatto, 0086-0551-62922329, [email protected]
In arruolamento
Beijing Municipality
Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, 100053, China
Weibi Chen, Contatto, 0086-010-83198899, [email protected]
In arruolamento
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Shenggen Chen, Contatto, 0086-0591-83357896, [email protected]
In arruolamento
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Zhijian Liang, Contatto, 0086-0771-5322120, [email protected]
In arruolamento
Guizhou
Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
Xiao Hu, Contatto, 0086-0851-85611278, [email protected]
In arruolamento
Hainan
The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China
Pengxiang Li, Contatto, [email protected]
Non ancora in arruolamento
Hebei
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China
Jia Tian, Contatto, 0086-0311-87156771, [email protected]
In arruolamento
Heilongjiang
The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
Linlin Sun, Contatto, [email protected]
In arruolamento
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Wenjing Deng, Contatto, 0086-0371-66913114, [email protected]
Non ancora in arruolamento
Neimenggu
Chifeng Municipal Hospital, Chifeng, Neimenggu, 024000, China
Huijie Zhou, Contatto, 0086-0476-8331476, [email protected]
In arruolamento
Shandong
Qilu Hospital，Shandong University, Jinan, Shandong, 2500012, China
Qinzhou Wang, Contatto, 0086-0531-82166666, [email protected]
Non ancora in arruolamento
Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, Zhejiang, 310009, China
Lida Su, Contatto, 0086-0571-87783777, [email protected]
In arruolamento
Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China
Qinglin Yang, Contatto, 0086-010-58269911, [email protected]
Non ancora in arruolamento
The First Hospital of Jilin University, Jilin, 130021, China
Jie Cao, Contatto, 0086-0431-84808243, [email protected]
In arruolamento
Liaocheng People's Hospital, Liaocheng, 252000, China
Dong Guo, Dr, Contatto, 0086-13346252870, [email protected]
In arruolamento