Using exogenous ketone esters to treat refractory status epilepticus in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of exogenous ketone esters as an add-on treatment for children suffering from refractory generalized convulsive status epilepticus, a serious neurological emergency. The research aims to provide a rapid method to achieve ketosis, which is traditionally accomplished through a ketogenic diet that can be impractical in acute settings. By administering exogenous ketone esters, the study seeks to improve seizure control in patients who do not respond to standard anti-seizure medications. The trial is designed as a Phase 2 and Phase 3 interventional study to evaluate the safety and efficacy of this approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Pediatrics at Sohag University Hospital
  Sohag, Egypt Recruiting

Study contacts

• Study coordinator: Elsayed M Abdelkreem, MD, PhD
• Email: d.elsayedmohammed@med.sohag.edu.eg
• Phone: 01114232126

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Recovery after coma from serious brain injury or illness

  This observational study will follow adults who are unconscious due to a serious brain illness or injury to see what medical, neurological, psychological, and social factors are linked with recovery over time.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07614074

• Augmented kidney clearance in neurocritical care

  This project will test whether adults in the neuro-ICU with severe brain injury, stroke, seizures, or brain infections have faster kidney clearance (ARC) that can lower antiseizure and antibiotic drug levels.

  Recruiting at 3 sites University of Alberta · Lexington, Kentucky and 2 other locations · NCT07410624

• Ketamine added to levetiracetam to stop prolonged convulsive seizures

  This trial will test whether giving ketamine (two different doses) along with levetiracetam helps stop benzodiazepine-refractory status epilepticus in people age 1 and older.

  Recruiting at 36 sites Phase 3 University of Virginia · Birmingham, Alabama and 62 other locations · NCT06907173

• Improving prognosis for patients with Status Epilepticus

  This study is trying to find blood markers that can help predict how well patients with Status Epilepticus will recover in the ICU and how their thinking skills may change after they leave the hospital.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT06590883

• Using Rapid-Response EEG to Diagnose Seizures in Children

  This study is testing if a new quick EEG device can help doctors diagnose seizures in children faster than the standard method.

  Recruiting Children's Hospital at Montefiore · The Bronx, New York · NCT06564662

• Two-way video support for paramedics caring for infants with life-threatening breathing problems.

  This project will test whether a two-way video link with pediatric emergency doctors helps paramedics give better care to infants with life-threatening breathing problems during transport.

  Recruiting at 4 sites Boston Medical Center · Los Angeles, California and 8 other locations · NCT06441760

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.