Tests a ketone ester added to treatment for children with prolonged seizures
Tests added ketone ester in children with seizures that resist standard treatment.
Key facts
- Who runs it
- Sohag University
- Where
- Sohag, EgyptSee the site
- Trial code
- Registry title
- Exogenous Ketone Esters for Refractory Status Epileptics
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 50 people, planned
- Started
- 10 Jan 2023
- Planned end
- 1 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Exogenous ketone ester
- Record updated
- 27 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 1 to 10 years who have refractory generalized convulsive status epilepticus, a long seizure that does not stop with usual treatment. It tests a ketone ester drink added to usual care.
- Age
- 1 Year to 10 Years
- Sex
- All sexes can join.
- Disease stage
- Refractory generalized convulsive status epilepticus.
- Earlier treatment
- Cannot join if they recently took exogenous ketones, are on a ketogenic diet or other diet restrictions, had propofol in the last 24 hours, or take carbonic-anhydrase inhibitors.
- Biomarker or test result
- Ketosis (βHB > 2 mmol/L) is an exclusion, so blood ketone level matters. No other marker is asked for.
Main reasons for not taking part
- Informed consent cannot be obtained
- Unstable blood pressure, heart or breathing
- Traumatic brain injury
- Low or high blood sugar, metabolic acidosis or ketosis (βHB > 2 mmol/L (36 mg/dL))
- Severe liver, kidney, lung, heart, stomach and bowel, hormone or immune disease
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Refractory Generalized convulsive status epilepticus
Who cannot take part
- Current or recent (within the last 24 hours) propofol therapy
- Intake of carbonic-anhydrase inhibitors
- Failure to obtain informed consent
- Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems
- Allergies or any other contraindication to exogenous ketone esters
- Ketosis (βHB > 2 mmol/L)
- Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications
- Hemodynamic or cardio-respiratory instability
- Traumatic brain injury
- Hypo-/hyperglycemia
- Metabolic acidosis
- Malnutrition/obesity
- Limitations to nasogastric tube feeding
- Inborn errors of metabolism
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 10 years old?
Where in Egypt
- Department of Pediatrics at Sohag University HospitalSohag, EgyptContact: Abdelrahim A Sadek, MD, PhDTaking people
About the trial
What the trial wants to find out
This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus
The 2 groups in the trial
- Study groupTreatment being tested
Children receiving exogenous ketone esters + standard of care
Treatment: Exogenous ketone ester
- Control groupNo study treatment, for comparison
Children receiving only standard of care
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics
- Plain-language title
- Tests a ketone ester added to treatment for children with prolonged seizuresGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05674552, who can take part
- Record updated
- 27 November 2024