NCT07496749 KD Treatment for Super-refractory Status Epilepticus
| NCT ID | NCT07496749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Super-refractory Status Epilepticus |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-10-20 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07496749 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Super-refractory Status Epilepticus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07496749 currently recruiting?
Yes, NCT07496749 is actively recruiting participants. Contact the research team at chenweibi@126.com for enrollment information.
Where is the NCT07496749 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Fuzhou, China, Nanning, China and 10 additional locations.
Who is sponsoring the NCT07496749 clinical trial?
NCT07496749 is sponsored by Xuanwu Hospital, Beijing. The trial plans to enroll 84 participants.