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)
Time to cessation of SRSE — 2 weeks 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.
Trial sites (14)
Facility
City
Region
Status
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
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.
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