Can a ketone drink clear brain fog in the ICU?
NCT ID NCT07364162
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests whether a special ketone drink is safe and can help reduce confusion (delirium) in ICU patients. Delirium is common in the ICU and can lead to long-term thinking and memory problems. The study will give 40 adults either the ketone drink or a placebo to see if it lessens the severity of delirium.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 International Normalized Ratio (INR) \> 3, when not attributable to therapeutic anticoagulation or another clearly non-hepatic cause. 7. Refractory shock, defined as a sustained norepinephrine requirement ≥30 µg/min, or norepinephrine-equivalent vasopressor dose, despite appropriate resuscitation, or ongoing escalation of vasopressor support at the time of enrollment. 8. Pregnancy (positive urine/serum hCG at screening or known pregnancy) or breastfeeding. 9. Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing. 10. ADH/ALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned. 11. Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE \>4.5. 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. 12. 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. 13. Active seizures during this ICU admission being treated with intravenous benzodiazepines. 14. 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). 15. Admission to ICU only for post-operative monitoring or frequent neurologic assessments. 16. Incarcerated status. 17. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal. 18. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and/or surrogate refusal. 19. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available. 20. Current enrollment in a study that does not allow co-enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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