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NCT Number: NCT05674552

Exogenous Ketone Esters for Refractory 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

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Key information

Conditions

Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Pediatrics at Sohag University Hospital

Sohag, 82524, Egypt

Location status: Recruiting

Location contact

Abdelrahim A Sadek, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exogenous ketone ester

Drug

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.

Primary outcomes

  1. 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])

Secondary outcomes

  1. 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])

  2. 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])

  3. 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])

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Other outcomes

  1. 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

  2. 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

  3. Change in hemoglobin level

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in hemoglobin level

  4. Change in leukocyte count

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in leukocyte count

  5. Change in platelets count

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in platelets count

  6. Change in serum sodium level

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in serum sodium level

  7. Change in serum potassium level

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in serum potassium level

  8. Change in CRP level

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in CRP level

  9. Change in lipid profile

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in lipid profile

  10. 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

  11. Change in serum creatinine level

    Time frame: From baseline to 1 hour and 12 hours study timepoints

    Change in serum creatinine level

Study contacts

Contact information is provided by the study sponsor or research team.

Elsayed M Abdelkreem, MD, PhD

CONTACT

[email protected]

01114232126

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Acronym: EKERSE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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