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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111047
Enrollment
Unknown
Registered
2025-10-24
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Super-refractory Status Epilepticus

Interventions

Experimental:The experimental arm is defined by the addition of the Ketogenic Diet to standard medical therapy
Active Comparator: standard medical therapy

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. patients diagnosed with super-refractory sustained status epilepticus (SRSE) whose initial antiepileptic sustained status epilepticus (SE) treatment consisted of intravenous benzodiazepines and an antiepileptic medications (ASMs, such as valproate, levetiracetam, or phenobarbital) as well as anaesthetics (e.g., propofol) for 24 hours of SE that did not terminate, or who relapsed after reduction of anaesthetics; 2. be between 14 and 80 years of age and of either sex; and 3. the patient's legal guardian has signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. fatty acid transport or oxidation disorders, pyruvate carboxylase deficiency and porphyrias; 2. intolerance of enteral nutrition, including intestinal obstruction; 3. use of propofol within 24 hours; 4. haemodynamic or cardiorespiratory instability (systolic blood pressure 5 times the upper limit of normal, and total bilirubin > 10 mg/dl); 6. pancreatitis; 7. pregnancy; 8. metabolic instability (blood glucose 160 mmol/L); 9. Combined septicaemia; 10. Combined with uremia; 11. SE due to hypoxic-ischemic brain injury.

Design outcomes

Secondary

MeasureTime frame
KD Improvement in prognosis;Feasibility of the KD diet;

Primary

MeasureTime frame
Efficacy in controlling SRSE;

Countries

China

Contacts

Public ContactWeibi Chen

Xuanwu Hospital Capital Medical University

chenweibi@126.com+86 150 1025 5903

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026