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KD Treatment for Super-refractory Status Epilepticus

NCT07496749 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-15

No results posted yet for this study

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).

Conditions

  • Super-refractory Status Epilepticus

Interventions

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.

DRUG

Standard Medical Therapy

Standard Medical Therapy include continuous intravenous infusion of an anesthetic agent, such as midazolam (starting regimen: 0.2 mg/kg IV bolus followed by continuous infusion of 0.1-0.6 mg/kg/h), titrated to seizure termination

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2027-02-01
Completion
2027-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07496749 on ClinicalTrials.gov