[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649851":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":48,"locations":53,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":30,"enrollmentInfo":86,"targetDuration":30,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":102,"whyStopped":30,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Intensive care unit patients with policy allocation to delayed medical nutrition therapy in main study: no enteral nutrition, parenteral nutrition or maintenance glucose solutions for first 72 hours.",[13],"Other: Delayed nutrition",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Intensive care unit patients with policy allocation to standard care in main study: nutritional management according to regular unit protocols.",[19],"Other: Standard nutrition",{"label":21,"type":16,"description":22,"interventionNames":23},"Healthy reference controls","Healthy subjects undergoing 72 hour fast with same blood sampling procedure as in ICU.",[24],"Other: Fasting",[26,31,35],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Delayed nutrition","Intervention Policy (A): Withhold nutrition and glucose solutions (First 72 h)\n\n* No enteral nutrition (EN) and no parenteral nutrition (PN) for the first 72 hours from ICU admission time (t=0).\n* No glucose-containing maintenance IV solutions during the first 72 hours. Balanced crystalloids or normal saline permitted per clinical need.\n* 5% glucose solution permitted as vehicle for IV medications as necessary (according to local standard), or as treatment for hypernatremia\n* Oral intake permitted ad lib if the patient is awake, willing and able to eat safely.\n* Micronutrients: daily vitamins and trace elements are allowed per local practice.\n* Protein supplements are not allowed unless part of the standard oral diet.\n* Arterial or venous blood glucose measurement every 4h.\n* Rescue glucose will be administered according to local protocol.\n* After 72 hours, feeding transitions to usual care at clinician discretion (including EN\u002FPN initiation and caloric\u002Fprotein targets).",[9],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Standard nutrition","Control Policy (B): Standard of Care\n\n* Initiation and advancement of EN\u002FPN and use of glucose-containing maintenance fluids per local practice from admission.\n* Arterial or venous blood glucose measurement every 4h.\n* Insulin and glycaemic control per local protocols.",[15],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Fasting","72-hour fasting period with water and non-caloric beverages.",[21],[40,44],{"name":41,"affiliation":42,"role":43},"Martin Sundström Rehal, MD PhD","Karolinska University Hospital\u002FKarolinska Institutet","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":47},"Olav Rooyackers, PhD","Karolinska University Hospital\u002FKarolinska Institute","STUDY_CHAIR",[49],{"name":41,"role":50,"phone":51,"phoneExt":30,"email":52},"CONTACT","+46-8-12381507","martin.sundstrom-rehal@regionstockholm.se",[54],{"facility":55,"status":30,"city":56,"state":30,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Karolinska University Hospital Huddinge","Stockholm","14186","Sweden","SE",{"type":61,"coordinates":62},"Point",[63,64],18.06871,59.32938,{"lat":64,"lon":63},[67],{"name":41,"role":50,"phone":68,"phoneExt":30,"email":52},"+46812381507",{"type":43,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Martin Sundstrom Rehal","Principal Investigator",[73],{"name":74,"class":6},"Tartu University Hospital","100649851","ketosis-immune-function-and-metabolic-adaptation-in-response-to-short-term-fasting-in-critical-illness-100649851",false,"NCT07738536","Ketosis, Immune Function and Metabolic Adaptation in Response to Short-term Fasting in Critical Illness","KETOsis, Immune Function and Metabolic Adaptation in Response to Short-Term Fasting in Critical Illness (KETO-FAST): A Translational Substudy of the FAST-ICU Cluster-randomized Cross-over Trial.","KETO-FAST","Inclusion Criteria:\n\n1. Adult (≥18 years).\n2. ICU admission (index admission to the participating ICU).\n\nExclusion Criteria:\n\n1. The patient requires intravenous glucose infusion, enteral nutrition or parenteral nutrition according to the attending clinician's assessment,\n2. Acute or acute-on-chronic liver failure\n3. Moderate hypernatremia ( \\>150 mmol\u002FL)\n4. Diabetic ketoacidosis or hyperosmolar hyperglycemic state at admission,\n5. Pregnancy,\n6. Exclusive end-of-life care (no other treatment goal than comfort care for end of life),\n7. Organ donor,\n8. Prior enrolment in this trial during the same hospitalisation,\n9. Patients with a metabolic disease requiring specific diet and patients with clinical need for a ketogenic diet.\n10. Patients already enrolled in other interventional studies on nutrition, intravenous fluids, phosphate supplementation or hormonal therapies that influence glucose homeostasis.\n11. Inclusion not possible due to site-specific regulatory issues regarding the ethical approval or informed consent procedure.",true,"ALL","18 Years",{"count":87,"type":88},200,"ESTIMATED","INTERVENTIONAL",[91],"NA","KETO-FAST is a pre-planned translational substudy of the FAST-ICU cluster-randomized cross-over trial. The substudy will characterize ketone body production and associated metabolic, autophagy-related, and immune cellular responses during the first 72 hours after intensive care unit admission in critically ill patients exposed to delayed nutrition compared with patients receiving standard care.\n\nPatients enrolled in FAST-ICU at designated participating centers will undergo serial blood sampling during the first 72 hours after ICU admission. Plasma ketone body concentrations, targeted metabolomics, serum-induced cellular responses in vitro, leukocyte autophagy markers, and immune cell phenotypes and functional markers will be assessed. In addition, 10 healthy volunteers will perform a 72-hour fast with blood sampling to provide reference values from non-critically ill subjects.",[94,95,96,97],"Critical Illness","Fasting State","Ketosis","Nutrition",[99,100,36,96,101],"Critical Care","Intensive care","Calorie restriction","NOT_YET_RECRUITING","2026-07-29",{"date":105,"type":106},"2026-07-31","ACTUAL",{"date":108,"type":88},"2026-08-31",{"date":110,"type":88},"2027-07-31",{"name":5,"class":6},1]