Using exogenous ketone esters to treat refractory status epilepticus in children
Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics
This study is testing if giving kids with severe seizures a special drink can help control their seizures when regular medications aren't working.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Year to 10 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT05674552 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of exogenous ketone esters as an add-on treatment for children suffering from refractory generalized convulsive status epilepticus, a serious neurological emergency. The research aims to provide a rapid method to achieve ketosis, which is traditionally accomplished through a ketogenic diet that can be impractical in acute settings. By administering exogenous ketone esters, the study seeks to improve seizure control in patients who do not respond to standard anti-seizure medications. The trial is designed as a Phase 2 and Phase 3 interventional study to evaluate the safety and efficacy of this approach.
Who should consider this trial
Good fit: Ideal candidates for this study are children experiencing refractory generalized convulsive status epilepticus.
Not a fit: Patients with severe underlying health conditions or contraindications to exogenous ketone esters may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a rapid and effective option for controlling seizures in children with refractory status epilepticus.
How similar studies have performed: While the ketogenic diet has been used for drug-resistant epilepsy, the use of exogenous ketone esters in this context is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Refractory Generalized convulsive status epilepticus. Exclusion Criteria: * Failure to obtain informed consent. * Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications. * Hemodynamic or cardio-respiratory instability. * Traumatic brain injury. * Hypo-/hyperglycemia. * Metabolic acidosis. * Ketosis (βHB \> 2 mmol/L). * Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems. * Malnutrition/obesity. * Limitations to nasogastric tube feeding. * Inborn errors of metabolism. * Allergies or any other contraindication to exogenous ketone esters. * Current or recent (within the last 24 hours) propofol therapy. * Intake of carbonic-anhydrase inhibitors.
Where this trial is running
Sohag
- Department of Pediatrics at Sohag University Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Elsayed M Abdelkreem, MD, PhD
- Email: d.elsayedmohammed@med.sohag.edu.eg
- Phone: 01114232126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.