[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589263":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":33,"locations":11,"responsibleParty":39,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":11,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":11},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketone ester followed by placebo","EXPERIMENTAL",null,[13,14],"Dietary Supplement: Ketone ester","Dietary Supplement: Placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"Placebo followed by ketone ester",[13,14],[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DIETARY_SUPPLEMENT","Ketone ester","Ketone ester: 3-hydroxybutyrate as enteral bolus (500 mg\u002Fkg)",[9,16],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Placebo","Maltodextrin (isovolumic and isocaloric placebo) as enteral bolus",[9,16],[29],{"name":30,"affiliation":31,"role":32},"Tor Biering-Sørensen, MD, MPH, MSc, PhD","Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Katrine F Bernholm, MD","CONTACT","0045 24909488","katrine.feldballe.bernholm@regionh.dk",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Tor Biering-Sørensen","Professor, MD, MSc, MPH, PhD","100589263","hemodynamic-effects-of-ketone-esters-in-patients-with-sepsis-induced-cardiomyopathy-100589263",false,"NCT06952140","Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy","KetoSIC","Inclusion Criteria:\n\n* Patients ≥ 18 years of age admitted to the the intensive care unit (ICU)\n* LVEF \\\u003C 50% determined by a screening echocardiography and analysed according to the Simpson biplane method\n* Ability for study personnel to perform transthoracic echocardiography\n* Suspected or documented infection (suspected infection is defined as ongoing antibiotic treatment and\u002For body fluid culture sampling performed within 72 hours before screening)\n\nExclusion Criteria:\n\n* Diagnosis of heart failure with reduced ejection fraction prior to ICU admission according to health records\n* Surgical cause of ICU admission\n* For patients in shock: Other primary causes of shock than sepsis (i.e. hypovolemia, haemorrhage, cardiogenic etiology, pulmonary embolism, anaphylaxis)\n* Blood pH \\\u003C 7.20\n* Severe gastroparesis\n* Inability to position a nasogastric tube","ALL","18 Years",{"count":53,"type":54},12,"ESTIMATED","INTERVENTIONAL",[57],"NA","Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with a high mortality rate in the ICU. Sepsis induced cardiomyopathy (SICM) is a multi-factorial process that appears in approximately 50% of patients with sepsis\u002Fseptic shock and is associated with increased mortality. It is suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per ATP-molecule produced and that the failing human heart increases the capacity to metabolize ketones. Previous studies have found acute beneficial hemodynamic effects of ketone esters in patients with chronic heart failure and cardiogenic shock, respectively. Improved hemodynamics and reduced systemic oxygen consumption as an effect of ketone esters might be of great benefit in patients admitted to the ICU. Thus, the investigators aim to investigate the hemodynamic effects of ketone esters in patients with sepsis induced cardiomyopathy in this randomized, placebo-controlled, double-blinded, cross-over, acute intervention study. .",[60],"Sepsis Induced Cardiomyopathy",[62,63,64,21,65,66,67,68,69],"Sepsis induced cardiomyopathy","Sepsis","Hemodynamics","Ketones","Echocardiography","Randomized controlled trial","Cross-over trial","Cardiovascular","NOT_YET_RECRUITING","2026-03-03",{"date":73,"type":74},"2026-03-04","ACTUAL",{"date":76,"type":54},"2026-03-10",{"date":78,"type":54},"2027-12-31",{"name":41,"class":6}]