Ketogenic Diet Treatment for Super-refractory Status Epilepticus: a Multicenter, Prospective, Randomized, Controlled Trial
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 80
Healthy Volunteers: f
View:
• (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
Locations
Other Locations
China
Beijing Tongren Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Department of Neurology, Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Chifeng Municipal Hospital
RECRUITING
Chifeng
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
The Second Affiliated Hospital of Hainan Medical University
NOT_YET_RECRUITING
Haikou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hanzhou
The First Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The First Hospital of Jilin University
RECRUITING
Jilin
Qilu Hospital，Shandong University
NOT_YET_RECRUITING
Jinan
Liaocheng People's Hospital
RECRUITING
Liaocheng
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Weibi Chen
chenweibi@126.com
0086-010-83198424
Backup
Gang Liu
liugangqingyi@sina.com
010-83198899
Time Frame
Start Date:2025-10-20
Estimated Completion Date:2027-03-01
Participants
Target number of participants:84
Treatments
Experimental: standard medical therapy for SRSE and KD therapy
the experimental arm is defined by the addition of the Ketogenic Diet to standard medical therapy
Active_comparator: standard care group
active comparator arm receives standard medical therapy alone.