Clinical trial NCT05674552: Exogenous Ketone Esters for Refractory Status Epileptics
Official title: Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Status Epilepticus
Keywords: Status epilepticus
Refractory status epilepticus
Generalized convulsive status epilepticus
Exogenous ketone esters
Children
Seizures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible children will be randomized into two equal-sized groups. Study group: will receive exogenous ketone esters plus standard of care. Control group: will receive only standard of care.
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients achieving electroclinical cessation of seizures
timeFrame: 60 minutes
Secondary outcomes:
measure: Proportion of patients achieving electroclinical cessation of seizures
timeFrame: 12 hours
measure: Time to electroclinical cessation of seizures
timeFrame: 24 hours
measure: Proportion of patients achieving electroclinical seizure freedom
timeFrame: 24 hours
measure: Proportion of patients with super-refractory status epilepticus
timeFrame: 24 hours
measure: Proportion of patients with adverse gastrointestinal effects
timeFrame: 24 hours
measure: Change in blood beta-hydroxybutyrate level
timeFrame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
measure: Change in blood glucose level
timeFrame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
measure: Change in blood pH
timeFrame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Other outcomes:
measure: Change in blood bicarbonates level
timeFrame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
measure: Change in blood lactate level
timeFrame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
measure: Change in hemoglobin level
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in leukocyte count
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in platelets count
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in serum sodium level
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in serum potassium level
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in CRP level
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in lipid profile
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in blood alanine transaminase level
timeFrame: From baseline to 1 hour and 12 hours study timepoints
measure: Change in serum creatinine level
timeFrame: From baseline to 1 hour and 12 hours study timepoints
Locations:
city: Sohag
country: Egypt
facility: Department of Pediatrics at Sohag University Hospital
Study officials:
affiliation: Sohag University
name: Abdelrahim A Sadek, MD, PhD
role: STUDY_CHAIR
References:
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