RecruitingNot ApplicableNCT07496749

KD Treatment for Super-refractory Status Epilepticus

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


Sponsor

Xuanwu Hospital, Beijing

Enrollment

84 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 YearsMax Age: 80 Years

Inclusion Criteria1

  • (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

Exclusion Criteria1

  • (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.

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Interventions

OTHERthe 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.


Locations(15)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Department of Neurology, Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Chifeng Municipal Hospital

Chifeng, Neimenggu, China

Qilu Hospital,Shandong University

Jinan, Shandong, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

The First Hospital of Jilin University

Jilin, China

Liaocheng People's Hospital

Liaocheng, China

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NCT07496749