RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
Exogenous Ketone Esters for Refractory Status Epileptics
Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Refractory Generalized convulsive status epilepticus.
Who Should NOT Join This Trial:
- Failure to obtain willing to sign a consent form.
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Exogenous 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)
Department of Pediatrics at Sohag University Hospital
Sohag, Egypt