Exogenous Ketone Esters for Refractory Status Epileptics

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University

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.