רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT07496749 (KD) עבור Super-refractory Status Epilepticus הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
KD Treatment for Super-refractory Status Epilepticus 84 תזונה
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07496749 (KD) הוא מחקר מסוג התערבותי עבור Super-refractory Status Epilepticus, שנמצא כעת במצב מגייס. המחקר התחיל ב-20 באוקטובר 2025 ומתוכנן לכלול 84 משתתפים. המחקר מנוהל על ידי Xuanwu Hospital, Beijing וצפוי להסתיים ב-1 במרץ 2027. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-27 במרץ 2026.
סיכום קצר
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).
תיאור מפורט
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...
כותרת רשמית
Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
מצבים רפואיים
Super-refractory Status Epilepticusפרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:מזהי מחקר נוספים
- KD
- KS2025230-001
מספר NCT
תחילת המחקר (בפועל)
2025-10-20
עדכון אחרון שפורסם
2026-03-27
סיום המחקר (מוערך)
2027-03-01
משתתפים (מתוכנן)
84
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
מגייס
מילות מפתח
ketogenic diet
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיstandard 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...הצג עוד |
משווה פעילstandard 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...הצג עוד |
מדדי תוצאה ראשיים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד, מבוגר, גיל שלישי
גיל מינימלי למחקר
14 Years
מגדרים מוערכים למחקר
הכל
(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, Beijingהגורם האחראי למחקר
Weibi Chen, חוקר ראשי, Chief Physician and associate Professor, Xuanwu Hospital, Beijing
איש קשר מרכזי למחקר
איש קשר: Weibi Chen, 0086-010-83198424, [email protected]
איש קשר: Gang Liu, 010-83198899, [email protected]
15 מיקומי המחקר ב-1 מדינות
Anhui
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China
Yajuan Hu, Dr, איש קשר, 0086-0551-62922329, [email protected]
מגייס
Beijing Municipality
Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, 100053, China
Weibi Chen, איש קשר, 0086-010-83198899, [email protected]
מגייס
Fujian
Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Shenggen Chen, איש קשר, 0086-0591-83357896, [email protected]
מגייס
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Zhijian Liang, איש קשר, 0086-0771-5322120, [email protected]
מגייס
Guizhou
Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
Xiao Hu, איש קשר, 0086-0851-85611278, [email protected]
מגייס
Hainan
The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China
Pengxiang Li, איש קשר, [email protected]
טרם החל גיוס
Hebei
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China
Jia Tian, איש קשר, 0086-0311-87156771, [email protected]
מגייס
Heilongjiang
The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
Linlin Sun, איש קשר, [email protected]
מגייס
Henan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Wenjing Deng, איש קשר, 0086-0371-66913114, [email protected]
טרם החל גיוס
Neimenggu
Chifeng Municipal Hospital, Chifeng, Neimenggu, 024000, China
Huijie Zhou, איש קשר, 0086-0476-8331476, [email protected]
מגייס
Shandong
Qilu Hospital，Shandong University, Jinan, Shandong, 2500012, China
Qinzhou Wang, איש קשר, 0086-0531-82166666, [email protected]
טרם החל גיוס
Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, Zhejiang, 310009, China
Lida Su, איש קשר, 0086-0571-87783777, [email protected]
מגייס
Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China
Qinglin Yang, איש קשר, 0086-010-58269911, [email protected]
טרם החל גיוס
The First Hospital of Jilin University, Jilin, 130021, China
Jie Cao, איש קשר, 0086-0431-84808243, [email protected]
מגייס
Liaocheng People's Hospital, Liaocheng, 252000, China
Dong Guo, Dr, איש קשר, 0086-13346252870, [email protected]
מגייס