Actively Recruiting

Phase Not Applicable
Age: 14Years - 80Years
All Genders
NCT07496749

KD Treatment for Super-refractory Status Epilepticus

Led by Xuanwu Hospital, Beijing · Updated on 2026-03-27

84

Participants Needed

15

Research Sites

71 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

KD Treatment for Super-refractory Status Epilepticus

Who Can Participate

Age: 14Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with super-refractory status epilepticus (SRSE) that continues or returns after initial treatment including benzodiazepines, anti-seizure medication, and continuous anesthetic for 24 hours
  • Age between 14 and 80 years, any gender
  • Signed informed consent provided by the patient's legal guardian
Not Eligible

You will not qualify if you...

  • Patients with lipid metabolism disorders such as carnitine deficiency, fatty acid oxidation defects, and related enzyme deficiencies
  • Intolerance to enteral feeding (e.g., intestinal obstruction)
  • Receipt of propofol infusion within 24 hours
  • Hemodynamic instability requiring high-dose vasopressors (systolic BP <90 mmHg or diastolic BP <60 mmHg)
  • Liver failure with elevated liver enzymes, blood ammonia, or bilirubin levels
  • Pancreatitis
  • Pregnancy
  • Metabolic instability including low blood glucose, acidic blood pH, or abnormal sodium levels
  • Complications from sepsis
  • Complications from diabetes insipidus
  • Status epilepticus caused by hypoxic-ischemic brain injury

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230022

Actively Recruiting

2

Department of Neurology, Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

3

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

4

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530021

Actively Recruiting

5

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China, 550002

Actively Recruiting

6

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China, 570311

Not Yet Recruiting

7

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050031

Actively Recruiting

8

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150001

Actively Recruiting

9

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Not Yet Recruiting

10

Chifeng Municipal Hospital

Chifeng, Neimenggu, China, 024000

Actively Recruiting

11

Qilu Hospital,Shandong University

Jinan, Shandong, China, 2500012

Not Yet Recruiting

12

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, Zhejiang, China, 310009

Actively Recruiting

13

Beijing Tongren Hospital, Capital Medical University

Beijing, China, 100730

Not Yet Recruiting

14

The First Hospital of Jilin University

Jilin, China, 130021

Actively Recruiting

15

Liaocheng People's Hospital

Liaocheng, China, 252000

Actively Recruiting

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Research Team

W

Weibi Chen

CONTACT

G

Gang Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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