Exogenous Ketone Esters for Refractory Status Epileptics

Phase 3RecruitingNCT05674552

Sohag University50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Status Epilepticus

Interventions

Exogenous ketone esterDRUG

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 10 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Pediatrics at Sohag University Hospital

Sohag, Egypt

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients achieving electroclinical cessation of seizures

Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])

Time frame: 60 minutes

Secondary Outcomes

Proportion of patients achieving electroclinical cessation of seizures

Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])

Time frame: 12 hours

Time to electroclinical cessation of seizures

Time to cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])

Time frame: 24 hours

Proportion of patients achieving electroclinical seizure freedom

Proportion of patients achieving freedom from BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography \[EEG\])

Time frame: 24 hours

Proportion of patients with super-refractory status epilepticus

Proportion of patients with persistent seizures for 24 hours or more after initiation of 3rd line medications (anesthetics) or recurrence of seizure during withdrawal of the anesthetics

Time frame: 24 hours

Proportion of patients with adverse gastrointestinal effects

Proportion of patients with adverse gastrointestinal effects (vomiting, diarrhea, abdominal pain) evaluated by direct observation and patient-reporting

Time frame: 24 hours

Central Contacts

Elsayed M Abdelkreem, MD, PhD

CONTACT

01114232126 d.elsayedmohammed@med.sohag.edu.eg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.