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Clinical Trials in China / NCT07496749
Recruiting Not applicable

KD Treatment for Super-refractory Status Epilepticus

NCT07496749 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2025-10-20
Last updated
2026-05-15

Condition(s) studied

Super-refractory Status Epilepticus

Investigational drug(s) / intervention(s)

the ketogenic dietStandard 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 0.5:1 per week.

Standard Medical Therapy: Standard Medical Therapy include continuous intravenous infusion of an anesthetic agent, such as midazolam (starting regimen: 0.2 mg/kg IV bolus followed by continuous infusion of 0.1-0.6 mg/kg/h), titrated to seizure termination

Study 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

Sex
ALL
Min age
14 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * Age between 14 and 80 years, regardless of gender. * The patient's legal guardian has provided signed informed consent. Exclusion Criteria: * 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. * Intolerance to enteral feeding (e.g., intestinal obstruction). * Receipt of propofol infusion within 24 hours. * Hemodynamic instability (systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg, requiring high-dose vasopressors for maintenance). * Liver failure (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], blood ammonia \>5 times the upper limit of normal; total bilirubin \>10 mg/dL \[171 μmol/L\]). * Pancreatitis. * Pregnancy. * Metabolic instability (blood glucose \<3.1 mmol/L, arterial blood pH \<7.2, serum sodium \<120 or \>160 mmol/L). * Septic shock. * Complicated by diabetes insipidus. * Status epilepticus caused by hypoxic-ischemic brain injury.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Department of Neurology, Xuanwu Hospital Capital Medical University Beijing Beijing Municipality Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Recruiting
Guizhou Provincial People's Hospital Guiyang Guizhou Recruiting
The Second Affiliated Hospital of Hainan Medical University Haikou Hainan Not Yet Recruiting
The First Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Recruiting
Chifeng Municipal Hospital Chifeng Neimenggu Recruiting
Qilu Hospital,Shandong University Jinan Shandong Not Yet Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine Hanzhou Zhejiang Recruiting
Beijing Tongren Hospital, Capital Medical University Beijing China Not Yet Recruiting
The First Hospital of Jilin University Jilin City China Recruiting
Liaocheng People's Hospital Liaocheng China Recruiting

More Xuanwu Hospital, Beijing trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07496749 on ClinicalTrials.gov ↗ ← All trials in China