Study of Exogenous Ketone Esters Added to Standard Care for Children Ages 1 to 10 With Refractory Generalized Convulsive Status Epilepticus

What this Trial Is About

Researchers are evaluating the use of add-on exogenous ketone esters to treat children with refractory generalized convulsive status epilepticus, a serious neurological emergency with high risks. The study aims to determine if exogenous ketone esters can help control seizures more quickly than standard treatments, especially since traditional options like benzodiazepines and second-line anti-seizure medications sometimes fail. The ketogenic diet has been used for drug-resistant epilepsy but is challenging to implement rapidly in emergencies, so exogenous ketone esters may offer a faster alternative. The study compares two groups of children aged 1 to 10 years one group receives exogenous ketone esters plus standard care, while the other receives standard care alone. The ketone esters are given by a nasogastric tube with a dose of 500 mgkg over 5 minutes, followed by repeated hourly doses of 125 mgkg for 8 hours. This protocol aims to rapidly induce ketosis to help control seizures. The study is randomized and unblinded, conducted from January 2023 through July 2025. Participants will be closely monitored with electroclinical assessments to track seizure cessation at multiple time points, including 60 minutes, 12 hours, and 24 hours after treatment. Blood tests will measure ketone levels, glucose, and pH changes over 12 hours. Researchers will also observe for gastrointestinal side effects and the occurrence of super-refractory status epilepticus. The study includes detailed follow-up to evaluate safety and effectiveness throughout the treatment period.

Exogenous Ketone Esters for Refractory Status Epileptics