[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491086":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Sohag University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","EXPERIMENTAL","Children receiving exogenous ketone esters + standard of care",[13],"Drug: Exogenous ketone ester",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Children receiving only standard of care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Exogenous ketone ester","500 mg\u002Fkg over 5 min administered by nasogastric tube, followed after 1 hr by repeated hourly doses of 125 mg\u002Fkg for 8 hrs.",[9],[26],{"name":27,"affiliation":5,"role":28},"Abdelrahim A Sadek, MD, PhD","STUDY_CHAIR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Elsayed M Abdelkreem, MD, PhD","CONTACT","01114232126","d.elsayedmohammed@med.sohag.edu.eg",[36],{"facility":37,"status":38,"city":39,"state":18,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Department of Pediatrics at Sohag University Hospital","RECRUITING","Sohag","82524","Egypt","EG",{"type":44,"coordinates":45},"Point",[46,47],31.69478,26.55695,{"lat":47,"lon":46},[50],{"name":27,"role":32,"phone":18,"phoneExt":18,"email":51},"abdoneurology@yahoo.com",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Elsayed Abdelkreem","Lecturer of Pediatrics","100491086","phase-2-exogenous-ketone-esters-for-refractory-status-epileptics-100491086",false,"NCT05674552","Exogenous Ketone Esters for Refractory Status Epileptics","Efficacy of Exogenous Ketone Esters for Children With Refractory Convulsive Status Epileptics","EKERSE","Inclusion Criteria:\n\n* Refractory Generalized convulsive status epilepticus.\n\nExclusion Criteria:\n\n* Failure to obtain informed consent.\n* Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions\u002Fmodifications.\n* Hemodynamic or cardio-respiratory instability.\n* Traumatic brain injury.\n* Hypo-\u002Fhyperglycemia.\n* Metabolic acidosis.\n* Ketosis (βHB \\> 2 mmol\u002FL).\n* Associated severe disease condition, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems.\n* Malnutrition\u002Fobesity.\n* Limitations to nasogastric tube feeding.\n* Inborn errors of metabolism.\n* Allergies or any other contraindication to exogenous ketone esters.\n* Current or recent (within the last 24 hours) propofol therapy.\n* Intake of carbonic-anhydrase inhibitors.","ALL","1 Year","10 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE2","PHASE3","This study aims to investigate the efficacy of add-on exogenous ketone esters for the treatment of children with refractory generalized convulsive status epilepticus",[76],"Status Epilepticus",[78,79,80,81,82,83],"Status epilepticus","Refractory status epilepticus","Generalized convulsive status epilepticus","Exogenous ketone esters","Children","Seizures","2024-11-26",{"date":86,"type":87},"2024-11-27","ACTUAL",{"date":89,"type":87},"2023-01-10",{"date":91,"type":69},"2025-07-01",{"name":5,"class":6},1]