Exogenous Ketone Esters for Refractory Status Epileptics
Recruiting · NCT05674552 · Interventional (participants receive a specific treatment) · Lead sponsor: Sohag University
View the official record on ClinicalTrials.gov →Interventions studied
Exogenous ketone ester
What this trial is about
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
Who can take part
Age range
1 Year to 10 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Department of Pediatrics at Sohag University Hospital - Sohag, Egypt