KD Treatment for Super-refractory Status Epilepticus

Recruiting now · Not applicable

Conditions studied: Super-refractory Status Epilepticus

In brief

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).

Key facts

Study ID

NCT07496749

Run by

Xuanwu Hospital, Beijing

People needed

84

Starts

2025-10-20

Expected to finish

2027-03-01

Last updated by the study team

2026-05-15

Who can join

Age: 14 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Liaocheng People's Hospital — Liaocheng, China (enrolling)
• Department of Neurology, Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (enrolling)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hanzhou, Zhejiang, China (enrolling)
• The First Hospital of Jilin University — Jilin City, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• Chifeng Municipal Hospital — Chifeng, Neimenggu, China (enrolling)
• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China
• Beijing Tongren Hospital, Capital Medical University — Beijing, China
• Qilu Hospital，Shandong University — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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