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)

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt

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NCT05674552


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