Exogenous Ketone Esters for Refractory Status Epileptics
Recruiting now · Phase 2/Phase 3
Conditions studied: Status Epilepticus
In brief
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
Key facts
- Study ID
- NCT05674552
- Run by
- Sohag University
- People needed
- 50
- Starts
- 2023-01-10
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2024-11-27
Who can join
Age: 1 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Refractory Generalized convulsive status epilepticus.
You may not qualify if…
- 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
- Department of Pediatrics at Sohag University Hospital — Sohag, Egypt (enrolling)
Full record on ClinicalTrials.gov
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