[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557261":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":66,"collaborators":18,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":18,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital of Cologne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional: Cyclic enteral nutrition with ketogenic nighttime fasting","ACTIVE_COMPARATOR","Interventional group:\n\n12 hours of enteral feeding (as per patients´individual calorimetric requirements measured by indirect calorimetry) followed by a fasting period of 12 hours supported by the supplementation of exogenous ketone salts.",[13],"Other: Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control: Conventional continuous enteral nutrition","NO_INTERVENTION","Control group Continuous enteral nutrition for 24 hours (as per patients´ individual caloric requirements defined by indirect calorimetry).",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Cyclic enteral feeding with nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)","12 hours of enteral feeding (as per patients´individual calorimetric requirements measured by indirect calorimetry) followed by a fasting period of 12 hours supported by the supplementation of exogenous ketone salts.",[9],[25],"cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation",[27],{"name":28,"affiliation":29,"role":30},"Bernd W Böttiger, Prof","University Hospital Cologne","STUDY_DIRECTOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Sandra E Stoll, MD, assProf.","CONTACT","+49221478","82054","sandraemilystoll@googlemail.com",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Fabian Dusse, PD, MD","40806","fabian.dusse@uk-koeln.de",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Department of Anesthesiology and Intensive Care Medicine","RECRUITING","Cologne","North Rhine-Westphalia","50937","Germany","DE",{"type":52,"coordinates":53},"Point",[54,55],6.95,50.93333,{"lat":55,"lon":54},[58,61,64],{"name":59,"role":34,"phone":60,"phoneExt":18,"email":37},"Sandra E Stoll, MD","+491735697566",{"name":59,"role":34,"phone":60,"phoneExt":62,"email":63},"Stoll","sandra-emily.stoll@gmx.de",{"name":59,"role":65,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Sandra Emily Stoll","Dr., Assistant Professor","100557261","ketonifast-cyclic-enteral-daytime-feeding-with-ketogenic-nighttime-fasting-100557261",false,"NCT06535815","KetoNiFast: Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting","KetoNiFast: Impact of Cyclic Enteral Daytime Feeding With Ketogenic Nighttime Fasting on Outcome of Critical Ill Patients.","KetoNiFast","Inclusion Criteria:\n\n* written informed consent to participate in this study\n* admission to ICU\n* enteral nutrition\n\nExclusion Criteria:\n\n* Severe liver dysfunction \u002F liver failure (Child Pugh \\>7 points \u002F category B)\n* Severe kidney dysfunction (KDIGO stage 3)\n* Total pancreatectomy \u002F insulin dependent diabetes mellitus (IDDM)\n* Pregnancy \u002F lactation\n* Hemoglobin concentration \\\u003C 80g\u002Fl\n* Severe metabolic disorders \u002F severe autoimmune diseases\n* Refractory metabolic or respiratory acidosis\n* Dysfunction of mitochondrial transport of fatty acids\n* Dysfunction of oxidation of fatty acids\n* Dysfunction of gluconeogenesis, production and reduction of ketones\n* Intermittent Porphyria\n* Severe cardiac arrhythmias \u002F cardiomyopathy\n* Contraindication against enteral nutrition\n* Lack of informed consent","ALL","18 Years",{"count":80,"type":81},130,"ESTIMATED","INTERVENTIONAL",[84],"NA","A physiological human nutrition includes circadian feeding and nighttime fasting during sleep. There is increasing evidence, that this natural fasting episode over nighttime majorly contributes to repair processes of the human body. So far, intensive care patients are normally enterally fed continuously, so that there is no circadian nutrition and no nighttime fasting. An enteral nutrition for 12 hours followed by a fasting period of 12 hours supported by exogenous ketone salts potentially improves the reconstitution of ICU patients compared to ICU patients who are continuously enterally fed.",[87,88,89],"Nutrition","Muscle Loss","Inflammatory Response",[91,92,93],"Ketogenic diet","ketogenic fasting","cyclic enteral nutrition","2024-08-04",{"date":96,"type":97},"2024-08-06","ACTUAL",{"date":99,"type":97},"2023-09-01",{"date":101,"type":81},"2026-03-01",{"name":5,"class":6},1]