[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620941":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":40,"locations":49,"responsibleParty":66,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketone monoester","EXPERIMENTAL",null,[13],"Drug: Ketone monoester",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,30],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Ketone monoester diluted to a total volume of 74 mL with water and administered enterally (oral\u002Ffeeding tube). Dosing is protocolized with an initial dose of 25 g and subsequent dose titration based on serum β-hydroxybutyrate levels to target a prespecified serum β-hydroxybutyrate range, administered every 6 hours for up to 7 days (or ICU discharge or death, whichever occurs first).",[9],[25,26,27,28,29],"(R)-3-hydroxybutyl (R)-3-hydroxybutyrate","D-β-hydroxybutyrate monoester","D-BHB monoester","(R)-hydroxybutyl (R)-3-hydroxybutyrate;","[(3R)-3-hydroxybutyl] (3R)-3-hydroxybutanoate)",{"type":21,"name":15,"description":31,"armGroupLabels":32,"otherNames":11},"Placebo consists of 74 mL of dextrose 50% in water (D50W) plus 50 mg sucrose octaacetate for taste matching; administered enterally (oral\u002Ffeeding tube) on the same schedule as the experimental arm.",[15],[34,37],{"name":35,"affiliation":5,"role":36},"E. Wes Ely, MD, MPH","STUDY_DIRECTOR",{"name":38,"affiliation":5,"role":39},"Ryan J Smith, MD, JD","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":11,"email":44},"CONTACT","(602) 538-5003","ryan.j.smith@vumc.org",{"name":46,"role":42,"phone":47,"phoneExt":11,"email":48},"Rebecca Abel, MA","6158753763","wes.ely@vumc.org",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Nashville","Tennessee","37232","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-86.78444,36.16589,{"lat":61,"lon":60},[64],{"name":38,"role":42,"phone":65,"phoneExt":11,"email":44},"+1 (602) 5385003",{"type":39,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Ryan Smith","Pulmonary & Critical Care Medicine Fellow, Vanderbilt University Medical Center","100620941","phase-2-exogenous-ketone-supplementation-in-icu-delirium-100620941",false,"NCT07364162","Exogenous Ketone Supplementation in ICU Delirium","Exogenous Ketone Ester Supplementation in ICU Delirium (KETONES ICU)","KETONES-ICU","Inclusion criteria:\n\n1. Adult patients (≥18 years old) admitted to the medical intensive care unit.\n2. Current ICU admission with anticipated ICU stay ≥24 hours.\n3. Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of enrollment.\n4. Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment.\n\nExclusion criteria:\n\n1. Severe metabolic acidosis at screening: blood gas pH \\\u003C7.20 or bicarbonate \\\u003C 8 mmol\u002FL.\n2. Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state.\n3. Hypoglycemia as an ICU admission diagnosis or glucose \\\u003C60 mg\u002FdL.\n4. Patients with a history of type 1 diabetes mellitus.\n5. Hemoglobin \\\u003C7.0.\n6. Fulminant hepatic failure or AST\u002FALT \\> 5× ULN or total bilirubin \\> 3 mg\u002FdL.\n7. Refractory shock (defined as norepinephrine dose ≥20 µg\u002Fmin or use of a second vasopressor agent).\n8. Pregnancy (positive urine\u002Fserum hCG at screening or known pregnancy).\n9. Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing.\n10. SGLT2 inhibitor use within the prior 7 days.\n11. ADH\u002FALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned.\n12. Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE \\>4.5, measured using a patient's qualified surrogate. This exclusion also pertains to mental illnesses requiring long-term institutionalization, acquired or congenital intellectual disability, severe neuromuscular disorders, Parkinson's disease, and Huntington's disease. It also excludes patients with severe deficits due to structural brain diseases such as stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema.\n13. Benzodiazepine dependency or alcohol dependency based on the medical team's decision to institute a specific treatment plan involving benzodiazepines or barbiturates (either as continuous infusions or intermittent intravenous boluses) for this dependency.\n14. Active seizures during this ICU admission being treated with intravenous benzodiazepines.\n15. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family\u002Fmedical team (e.g., likely to withdraw life support measures within 24 hours of screening).\n16. Admission to ICU only for post-operative monitoring or frequent neurologic assessments.\n17. Incarcerated status.\n18. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal.\n19. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and\u002For surrogate refusal.\n20. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available.\n21. Current enrollment in a study that does not allow co-enrollment.","ALL","18 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","Delirium is a common syndrome in intensive care unit (ICU) patients. Those experiencing delirium may suddenly feel confused, have trouble thinking clearly, struggle to pay attention, or see and hear things that are not real. Delirium is associated with worse long-term outcomes such as cognitive impairment, depression, and PTSD (post-traumatic stress disorder). This study examines whether an investigational medical-grade ketone supplement drink (ketone monoester \\[brand name: Ultrapure Ketone Monoester\\]) is safe and feasible to use in ICU patients, and to look for signals that it might reduce delirium or shorten its duration compared to a volume-, taste-, and calorie-matched placebo.",[87,88],"ICU Delirium","Critical Illness",[90,91,92,93,94],"ICU","Intensive Care Unit","Critical care","Critical illness","Ketones","2026-06-11",{"date":97,"type":98},"2026-06-15","ACTUAL",{"date":100,"type":98},"2026-06-09",{"date":102,"type":81},"2027-12-31",{"name":5,"class":6},1]