NCT07496749

KD Treatment for Super-refractory Status Epilepticus

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a multicenter, prospective, randomized, controlled, open-label clinical study to evaluate the efficacy and safety of ketogenic diet (KD) as an adjunctive therapy in patients with Super Refractory Status Epilepticus (SRSE). The study plans to enroll eligible SRSE patients. Participants will be randomly assigned in a 1:1 ratio to one of two groups: 1. Control Group: Receives standard medical therapy according to current guideline recommendations for SRSE management. 2. Intervention Group: Receives standard medical therapy plus a ketogenic diet intervention. The KD intervention will be administered via a nasogastric tube using a ketogenic formula. The nutritional goal is 25-30 kcal/kg, initiated at half-strength and advanced to the full caloric target within 72 hours. If no clinical improvement is observed within 2 weeks of initiating the KD, it will be discontinued. For responders, continuation is recommended. All patients in the KD group will receive concomitant daily nutritional supplements. The primary outcome measure is the efficacy of controlling SRSE within 2 weeks after randomization. Efficacy is defined as the cessation of both clinical and electrographic status epilepticus, as confirmed by continuous EEG monitoring. Key secondary outcomes include: * Safety evaluation, including all KD-related adverse events and in-hospital mortality. * Feasibility of KD (time to achieve ketosis, defined as blood beta-hydroxybutyrate level ≥1.2 mmol/L or urine ketones 1+). * Neurological and functional outcomes assessed by the modified Rankin Scale (mRS), Glasgow Outcome Scale-Extended (GOS-E), and quality of life (QOLIE-31) at discharge, 3 months, and 6 months. * Cognitive function (MMSE, MoCA) at 3 and 6 months. Statistical analysis will be performed on both the Full Analysis Set (FAS) and the Per-Protocol Set (PPS).

Conditions

• Super-refractory Status Epilepticus

Interventions

Type	Name	Description
OTHER	the 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.

Timeline

• Start date: 2025-10-20
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

15 sites across 1 country: China