RecruitingPhase 2Phase 3NCT05674552
Exogenous Ketone Esters for Refractory Status Epileptics
Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics
Sponsor
Sohag University
Enrollment
50 participants
Start Date
Jan 10, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
Eligibility
Min Age: 1 YearMax Age: 10 Years
Inclusion Criteria1
- Refractory Generalized convulsive status epilepticus.
Exclusion Criteria14
- 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.
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Interventions
DRUGExogenous ketone ester
500 mg/kg over 5 min administered by nasogastric tube, followed after 1 hr by repeated hourly doses of 125 mg/kg for 8 hrs.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05674552
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