NCT07364162 Exogenous Ketone Supplementation in ICU Delirium
| NCT ID | NCT07364162 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | ICU Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2026-06-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria: 1. Adult patients (≥18 years old) admitted to the medical intensive care unit. 2. Current ICU admission with anticipated ICU stay ≥24 hours. 3. Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of enrollment. 4. Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment. Exclusion criteria: 1. Severe metabolic acidosis at screening: blood gas pH \<7.20 or bicarbonate \< 8 mmol/L. 2. Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state. 3. Hypoglycemia as an ICU admission diagnosis or glucose \<60 mg/dL. 4. Patients with a history of type 1 diabetes mellitus. 5. Hemoglobin \<7.0. 6. Fulminant hepatic failure or AST/ALT \> 5× ULN or total bilirubin \> 3 mg/dL. 7. Refractory shock (defined as norepinephrine dose ≥20 µg/min or use of a second vasopressor agent). 8. Pregnancy (positive urine/serum hCG at screening or known pregnancy). 9. Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing. 10. SGLT2 inhibitor use within the prior 7 days. 11. ADH/ALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned. 12. 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. 13. 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. 14. Active seizures during this ICU admission being treated with intravenous benzodiazepines. 15. 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). 16. Admission to ICU only for post-operative monitoring or frequent neurologic assessments. 17. Incarcerated status. 18. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal. 19. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and/or surrogate refusal. 20. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available. 21. Current enrollment in a study that does not allow co-enrollment.
Contact & Investigator
E. Wes Ely, MD, MPH
STUDY DIRECTOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07364162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ICU Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07364162 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07364162 currently recruiting?
Yes, NCT07364162 is actively recruiting participants. Contact the research team at ryan.j.smith@vumc.org for enrollment information.
Where is the NCT07364162 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07364162 clinical trial?
NCT07364162 is sponsored by Vanderbilt University Medical Center. The principal investigator is E. Wes Ely, MD, MPH at Vanderbilt University Medical Center. The trial plans to enroll 40 participants.