Exogenous Ketone Esters for Refractory Status Epileptics

Launched by SOHAG UNIVERSITY · Dec 31, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a treatment called exogenous ketone esters can be for children experiencing a specific type of severe seizure called refractory generalized convulsive status epilepticus. This condition means that children have continuous seizures that do not respond to standard treatments. The researchers hope that adding these ketone esters to the treatment may help control the seizures better.

To be eligible for this trial, children need to have been diagnosed with refractory status epilepticus. However, there are some reasons a child might not be able to participate, such as recent use of certain diets or medications, serious health issues, or specific medical conditions. If a child joins the trial, they will receive the ketone esters along with their usual care to see if it helps reduce their seizures. The trial is currently recruiting participants, and it's open to children of all genders aged between 1 to 10 years old.

Gender

ALL

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.