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رادار التجارب AI
حالة التجربة السريرية NCT07496749 (KD) لـ Super-refractory Status Epilepticus هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة

KD Treatment for Super-refractory Status Epilepticus ٨٤ نظام غذائي

يقبل مشاركين
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07496749 (KD) هي دراسة تدخُّلية لـSuper-refractory Status Epilepticus وهي يقبل مشاركين. بدأت في ٢٨ ربيع الآخر ١٤٤٧ هـ مع خطة لتجنيد ٨٤ مشاركًا. يقودها Xuanwu Hospital, Beijing، ومن المتوقع اكتمالها بحلول ٢٢ رمضان ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ شوال ١٤٤٧ هـ.
الملخص
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).
وصف مفصل

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:

  1. Control Group: Receives standard medical therapy according...
عرض المزيد
العنوان الرسمي

Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial

الحالات الطبية
Super-refractory Status Epilepticus
المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:
معرّفات دراسة أخرى
  • KD
  • KS2025230-001
NCT معرّف
تاريخ البدء (فعلي)
2025-10-20
آخر تحديث مُنشور
2026-03-27
تاريخ الاكتمال (المقدر)
2027-03-01
عدد المشاركين المخطط لهم
٨٤
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
يقبل مشاركين
الكلمات الرئيسية
ketogenic diet
status epilepticus
refractory status epilepticus
encephalitis
intensive care unit
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةstandard 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...عرض المزيد
مقارن نشطstandard 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...عرض المزيد
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
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
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
طفل, بالغ, كبار السن
العمر الأدنى للدراسة
14 Years
الجنس المؤهل
الكل

(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, Beijing logoXuanwu Hospital, Beijing
الجهة المسؤولة عن الدراسة
Weibi Chen, المحقق الرئيسي, Chief Physician and associate Professor, Xuanwu Hospital, Beijing
جهة اتصال مركزية للدراسة
جهة اتصال: Weibi Chen, 0086-010-83198424, [email protected]
جهة اتصال: Gang Liu, 010-83198899, [email protected]
15 مواقع الدراسة في 1 بلدان

Anhui

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China
Yajuan Hu, Dr, جهة اتصال, 0086-0551-62922329, [email protected]
يقبل مشاركين

Beijing Municipality

Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, 100053, China
Weibi Chen, جهة اتصال, 0086-010-83198899, [email protected]
يقبل مشاركين

Fujian

Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China
Shenggen Chen, جهة اتصال, 0086-0591-83357896, [email protected]
يقبل مشاركين

Guangxi

The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China
Zhijian Liang, جهة اتصال, 0086-0771-5322120, [email protected]
يقبل مشاركين

Guizhou

Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China
Xiao Hu, جهة اتصال, 0086-0851-85611278, [email protected]
يقبل مشاركين

Hainan

The Second Affiliated Hospital of Hainan Medical University, Haikou, Hainan, 570311, China
Pengxiang Li, جهة اتصال, [email protected]
لم يبدأ القبول بعد

Hebei

The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050031, China
Jia Tian, جهة اتصال, 0086-0311-87156771, [email protected]
يقبل مشاركين

Heilongjiang

The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China
Linlin Sun, جهة اتصال, [email protected]
يقبل مشاركين

Henan

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Wenjing Deng, جهة اتصال, 0086-0371-66913114, [email protected]
لم يبدأ القبول بعد

Neimenggu

Chifeng Municipal Hospital, Chifeng, Neimenggu, 024000, China
Huijie Zhou, جهة اتصال, 0086-0476-8331476, [email protected]
يقبل مشاركين

Shandong

Qilu Hospital,Shandong University, Jinan, Shandong, 2500012, China
Qinzhou Wang, جهة اتصال, 0086-0531-82166666, [email protected]
لم يبدأ القبول بعد

Zhejiang

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hanzhou, Zhejiang, 310009, China
Lida Su, جهة اتصال, 0086-0571-87783777, [email protected]
يقبل مشاركين
Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China
Qinglin Yang, جهة اتصال, 0086-010-58269911, [email protected]
لم يبدأ القبول بعد
The First Hospital of Jilin University, Jilin, 130021, China
Jie Cao, جهة اتصال, 0086-0431-84808243, [email protected]
يقبل مشاركين
Liaocheng People's Hospital, Liaocheng, 252000, China
Dong Guo, Dr, جهة اتصال, 0086-13346252870, [email protected]
يقبل مشاركين