Exogenous Ketone Esters for Refractory Status Epileptics (EKERSE)

Sohag University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Status Epilepticus

Treatments: Drug: Exogenous ketone ester

Study type: Interventional

Funder types: Other

Identifiers

NCT05674552

Soh-Med-22-12-46

Details and patient eligibility

About

This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus

Full description

Generalized convulsive status epilepticus (GCSE) is a common neurological emergency in children with significant morbidity and mortality. Benzodiazepines (Bzs) are the initial anti-seizure medications (ASMs) for children with GCSE, but nearly a third of cases are not controlled by (Bzs). Moreover, about 40% of cases not responding to BZs are not controlled by second-line ASMs.

Ketogenic diet (KD) has been classically used for treating children with drug resistant epilepsy. Recently, KD has been used for refractory and super refractory status epilepticus. However, KD takes time to achieve ketosis and may be practically challenging in emergency situations and critically ill patients. Exogenous ketone esters (EKE) could be a more convenient and rapid way to achieve ketosis in acute settings.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Study group

Experimental group

Description:

Children receiving exogenous ketone esters + standard of care

Treatment:

Drug: Exogenous ketone ester

Control group

No Intervention group

Description:

Children receiving only standard of care