[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557200":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":18,"responsibleParty":43,"collaborators":18,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":18,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":72,"whyStopped":18,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":18},{"fullName":5,"class":6},"University Hospital of Cologne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional group: Cyclic enteral nutrition with ketogenic nighttime fasting","EXPERIMENTAL","Interventional group: Cyclic enteral daytime nutrition (12 hours) with ketogenic nighttime fasting (12 hours) with supplementation of exogenous ketones (ß-hydroxybutyrate) in the Intensive Care Setting.",[13],"Dietary Supplement: Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group: Conventional continuous enteral nutrition","NO_INTERVENTION","Continuous (24 hours) enteral nutrition in the Intensive Care Setting.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Cyclic enteral daytime feeding with ketogenic nighttime fasting and exogenous ketone salt supplementation (ß-hydroxybutyrate)","Nighttime fasting and ß-hydroxybutyrate supplementation",[9],[26],"cyclic nutrition with nighttime fasting and exogenous ß-hydroxybutyrate supplementation",[28],{"name":29,"affiliation":30,"role":31},"Bernd W Böttiger, Prof","University Hospital Cologne","STUDY_DIRECTOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Sandra E Stoll, MD, assProf.","CONTACT","+49221478","82054","sandraemilystoll@googlemail.com",{"name":40,"role":35,"phone":36,"phoneExt":41,"email":42},"Fabian Dusse, PD, MD","40806","fabian.dusse@uk-koeln.de",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Sandra Emily Stoll","MD, Ass. Professor","100557200","deliket-substudy-of-ketonifast-study-id-22-13981-100557200",false,"NCT06535022","DeliKet (Substudy of KetoNiFast Study ID 22-1398_1)","Impact of Cyclic, Daytime Enteral Nutrition and Ketogenic Nighttime Fasting on the Incidence of Postoperative Delirium in Critically Ill Patients","DeliKet","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission to an ICU\n* Start of enteral nutrition\n\nExclusion Criteria:\n\n* Severe liver insufficiency \u002F liver disease (Child Pugh \\> B or 7-9 points)\n* Post total Pancreatectomy \u002F Insulin-depending diabetes mellitus (IDDM)\n* Pregnancy \u002F Lactation\n* Hemoglobin-concentration \\\u003C 80g\u002Fl\n* Severe metabolic disorder \u002F severe autoimmune disease\n* Refractory respiratory or metabolic acidosis\n* Disorder of mitochondrial transportation of fatty acids\n* Disorder of the oxidation of fatty acids\n* Disorder of gluconeogenesis, der ketone body production or ketone body degradation\n* Intermittent porphyria\n* Severe arrhythmia \u002F cardiomyopathy\n* Contraindications against enteral nutrition\n* Missing informed consent","ALL","18 Years",{"count":58,"type":59},90,"ESTIMATED","INTERVENTIONAL",[62],"NA","Postoperative delirium is a common problem of the critically ill patient and associated with an increased mortality. Intermittent fasting and ketogenesis have been shown to be beneficial for maintaining a circadian rhythm and initiating anti-inflammatory repair mechanisms which could potentially be neuroprotective. However, so far there is little data if cyclic enteral feeding with ketogenic nighttime fasting might be beneficial for reducing the rate of postoperative delirium. The study hypothesis is that equicaloric cyclic enteral feeding (12 hrs) during daytime with ketogenic fasting and exogenous ketone supplementation at nighttime compared to continuous standard enteral nutrition (24 hours) decreases the incidence of postoperative delirium in critically ill patients.",[65,66,67],"Delirium","Ketogenic Dieting","Nutrition, Healthy",[69,70,71],"ketogenic diet","cyclic nutrition","postoperative delirium","NOT_YET_RECRUITING","2024-08-04",{"date":75,"type":76},"2024-08-06","ACTUAL",{"date":78,"type":59},"2024-09-01",{"date":80,"type":59},"2026-03-01",{"name":5,"class":6}]