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Exogenous Ketone Supplementation in ICU Delirium

Study acronym: KETONES-ICU
StatusRecruiting
PhasePhase 2
Started2026-06-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-20
Study Status, Eligibility v6
Eligibility criteria+145 characters
[...] tes mellitus. Hemoglobin <7.0. Fulminant hepatic failure or AST/ALTInternational >Normalized 5×Ratio ULN or total bilirubin(INR) > 3, mg/dLwhen not attributable to therapeutic anticoagulation or another clearly non-hepatic cause. Refractory shock, (defined as a sustained norepinephrine doserequirement ≥2030 µg/min, or usenorepinephrine-equivalent vasopressor dose, despite appropriate resuscitation, or ongoing escalation of a second vasopressor agent)support at the time of enrollment. Pregnancy (positive urine/serum hCG at screening or known pregnancy) or breastfeeding. Uncontrolled ileus or ga [...] [...]
2026-06-11
Study Status, Study Design v5
Phase changed: Phase 1 → Phase 2
Recruitment opened
2026-06-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Primary endpoint(s) modified2 to 1 entries
WasFeasibility: Proportion of participants achieving target peak serum β-hydroxybutyrate (1.5-3.5 mmol/L) on at least 50% of dosing days, Safety and tolerability: Number of participants with ≥1 prespecified safety or tolerability event
NowMean composite Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7) delirium severity score
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2026-06-05
Study Status, Outcome Measures v3
Secondary endpoints17 to 7 entries
DeliriumFeasibility: severityProportion scoreof participants achieving target peak serum β-hydroxybutyrate (1.5-3.5 mmol/L) on theat Confusionleast Assessment50% Methodof fordosing thedays Safety Intensiveand Caretolerability: Unit-7Number (CAM-ICU-7)of scale Changeparticipants fromwith baseline in serum interleukin-≥1 betaprespecified (IL-1β)safety concentration Changeor fromtolerability baseline in serum interleukin-6 (IL-6) concentration Change from baseline in serum interleukin-8 (IL-8) concentration Change from baseline in serum interleukin-10 (IL-10) concentration Change from baseline in [...] [...]
Primary endpoints2 to 1 entries
Feasibility:Mean Proportioncomposite ofConfusion participantsAssessment achievingMethod targetfor peakthe serumIntensive βCare Unit-hydroxybutyrate7 (1.5CAM-3.5 mmol/LICU-7) ondelirium atseverity least 50% of dosing days Safety and tolerability: Number of participants with ≥1 prespecified safety or tolerability eventscore
2026-06-01
Study Status v2
Start date2026-04-06→2026-06-09
2026-03-25
Study Status, Arms and Interventions, Eligibility v1
Start date2026-02-15→2026-04-06
InterventionsKetone supplementation (Drug), Placebo (Drug)→Ketone monoester (Drug), Placebo (Drug)
Eligibility criteria+410 characters
[...] nrollment. Exclusion criteria: Severe metabolic acidosis at enrollmentscreening: blood gas pH <7.20 or bicarbonate < 8 mmol/L. Diabetic ket [...] ith a history of type 1 diabetes mellitus. Hemoglobin <7.0. Renal failure requiring dialysis initiated or anticipated at enrollment (CRRT or iHD). Fulminant hepatic failure or AST/ALT > 5× ULN or total bilir [...] stitute a specific treatment plan involving benzodiazepines or barbiturates (either as continuous infusions or intermittent intravenous [...] ing or frequent neurologic assessments. Incarcerated status. Inability to obtain informed consent within 24 hours from [...]
2026-01-17
Original filing
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.
Trial Details
NCT Number NCT07364162
Lead Sponsor Vanderbilt University Medical Center
Conditions ICU Delirium, Critical Illness
Enrollment 40 participants
Start Date 2026-06-09
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-24