Exogenous Ketone Esters for Refractory Status Epileptics (NCT05674552) | Clinical Trial Compass
RecruitingPhase 2/3
Exogenous Ketone Esters for Refractory Status Epileptics
Egypt50 participantsStarted 2023-01-10
Plain-language 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
Who can participate
Age range1 Year – 10 Years
SexALL
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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.
What they're measuring
1
Proportion of patients achieving electroclinical cessation of seizures