Exogenous Ketone Supplementation in ICU Delirium

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: ICU Delirium, Critical Illness

In brief

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.

Key facts

Study ID

NCT07364162

Run by

Vanderbilt University Medical Center

People needed

40

Starts

2026-06-09

Expected to finish

2027-12-31

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (≥18 years old) admitted to the medical intensive care unit.
• Current ICU admission with anticipated ICU stay ≥24 hours.
• Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of enrollment.
• Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment.

You may not qualify if…

• Severe metabolic acidosis at screening: blood gas pH <7.20 or bicarbonate < 8 mmol/L.
• Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state.
• Hypoglycemia as an ICU admission diagnosis or glucose <60 mg/dL.
• Patients with a history of type 1 diabetes mellitus.
• Hemoglobin <7.0.
• Fulminant hepatic failure or AST/ALT > 5× ULN or total bilirubin > 3 mg/dL.
• Refractory shock (defined as norepinephrine dose ≥20 µg/min or use of a second vasopressor agent).
• Pregnancy (positive urine/serum hCG at screening or known pregnancy).
• Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing.
• SGLT2 inhibitor use within the prior 7 days.
• ADH/ALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned.
• 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.
• 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.
• Active seizures during this ICU admission being treated with intravenous benzodiazepines.
• Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family/medical team (e.g., likely to withdraw life support measures within 24 hours of screening).
• Admission to ICU only for post-operative monitoring or frequent neurologic assessments.
• Incarcerated status.
• Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal.
• Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and/or surrogate refusal.
• Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available.
• Current enrollment in a study that does not allow co-enrollment.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.