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NCT05674552
Exogenous Ketone Esters for Refractory Status Epileptics
Conditions: Status Epilepticus
Sex: All
Ages: 1 Year – 10 Years
Phase: PHASE2, PHASE3
Enrollment: 50
Sponsor: Sohag University
Location: Egypt
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 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.
Source: ClinicalTrials.gov (NCT05674552). StuddyBuddy aggregates publicly available trial information.