Ketogenic diet for super-refractory status epilepticus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label study that assigns eligible ICU patients with super-refractory status epilepticus 1:1 to standard therapy or standard therapy plus a ketogenic diet. The ketogenic diet is delivered by nasogastric tube with a target of 25–30 kcal/kg, started at half strength and advanced to full calories within 72 hours, and non-responders stop the diet after 2 weeks while responders are recommended to continue. The primary outcome is cessation of both clinical and electrographic status epilepticus within 2 weeks as confirmed by continuous EEG, and key secondary outcomes include safety, in-hospital mortality, and feasibility measures such as time to ketosis (blood beta-hydroxybutyrate ≥1.2 mmol/L). All patients in the ketogenic arm receive daily nutritional supplements and the protocol is carried out while patients are hospitalized at the participating centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Department of Neurology, Xuanwu Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Guizhou Provincial People's Hospital
  Guiyang, Guizhou, China Recruiting
• The First Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Study coordinator: Weibi Chen
• Email: chenweibi@126.com
• Phone: 0086-010-83198424

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoustic Stimulation During Sleep for Alzheimer’s Disease

  Researchers test whether playing gentle sounds during sleep can help people with Alzheimer’s disease see if their thinking improves compared with a sham sound.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07924657

• See if multimodal biomarkers can map changes from mild cognitive impairment to dementia

  This observational study tests whether clinical, blood, and brain-imaging markers can tell apart stages of cognitive decline and predict progression from mild cognitive impairment to dementia in about 600 people.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07876570

• Satralizumab in the early treatment of NMOSD attacks: a multicenter real-world study

  This study tests whether starting Satralizumab during an NMOSD attack is safe and helpful for adults with AQP4-IgG–positive NMOSD.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07762872

• Real-World Experience With the WEB Device for Intracranial Aneurysms

  This study tests how well the Woven EndoBridge device works in routine treatment of intracranial aneurysms in China across multiple centers.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07620626

• Multicenter Registry of Intracranial Dural Arteriovenous Fistulas in China

  This study will collect and analyze data from many hospitals in China to see how common intracranial dural AV fistulas are, how they’re treated, and what outcomes look like for patients.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07604688

• Preventive Analgesia With Anrikefon in Laparoscopic Gallbladder Surgery

  This study tests whether giving Anrikefon before or during laparoscopic cholecystectomy can reduce early postoperative pain.

  Recruiting Xuanwu Hospital, Beijing · Beijing, Beijing Municipality · NCT07566663

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.