Exogenous Ketone Esters for Refractory Status Epileptics (EKERSE)

February 3, 2024 updated by: Elsayed Abdelkreem, Sohag University

Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • Department of Pediatrics at Sohag University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Children receiving exogenous ketone esters + standard of care
Drug: Exogenous 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.
No Intervention: Control group
Children receiving only standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving electroclinical cessation of seizures
Time Frame: 60 minutes
Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography [EEG])
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving electroclinical cessation of seizures
Time Frame: 12 hours
Proportions of patients who achieve cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography [EEG])
12 hours
Time to electroclinical cessation of seizures
Time Frame: 24 hours
Time to cessation of BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography [EEG])
24 hours
Proportion of patients achieving electroclinical seizure freedom
Time Frame: 24 hours
Proportion of patients achieving freedom from BOTH clinical seizures (as observed clinically) AND electrical seizures (evaluated by electroencephalography [EEG])
24 hours
Proportion of patients with super-refractory status epilepticus
Time Frame: 24 hours
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
24 hours
Proportion of patients with adverse gastrointestinal effects
Time Frame: 24 hours
Proportion of patients with adverse gastrointestinal effects (vomiting, diarrhea, abdominal pain) evaluated by direct observation and patient-reporting
24 hours
Change in blood beta-hydroxybutyrate level
Time Frame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood level of beta-hydroxybutyrate
From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood glucose level
Time Frame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood level of glucose
From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood pH
Time Frame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood pH
From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood bicarbonates level
Time Frame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood bicarbonates level
From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood lactate level
Time Frame: From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in blood lactate level
From baseline to 30 minutes, 1 hour, 2 hours, 5 hours, 9 hours, and 12 hours study timepoints
Change in hemoglobin level
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in hemoglobin level
From baseline to 1 hour and 12 hours study timepoints
Change in leukocyte count
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in leukocyte count
From baseline to 1 hour and 12 hours study timepoints
Change in platelets count
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in platelets count
From baseline to 1 hour and 12 hours study timepoints
Change in serum sodium level
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in serum sodium level
From baseline to 1 hour and 12 hours study timepoints
Change in serum potassium level
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in serum potassium level
From baseline to 1 hour and 12 hours study timepoints
Change in CRP level
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in CRP level
From baseline to 1 hour and 12 hours study timepoints
Change in lipid profile
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in lipid profile
From baseline to 1 hour and 12 hours study timepoints
Change in blood alanine transaminase level
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in blood alanine transaminase (ALT) level
From baseline to 1 hour and 12 hours study timepoints
Change in serum creatinine level
Time Frame: From baseline to 1 hour and 12 hours study timepoints
Change in serum creatinine level
From baseline to 1 hour and 12 hours study timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Chair: Abdelrahim A Sadek, MD, PhD, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 18, 2022

First Submitted That Met QC Criteria

December 31, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-12-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Unidentified individual participant data (IPD) underlying study results will be available upon reasonable request

IPD Sharing Time Frame

Unidentified individual participant data (IPD) underlying study results will be available upon reasonable request 6-months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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