← Back to all trials
Not Yet Recruiting
NCT07364162
Exogenous Ketone Supplementation in ICU Delirium
Conditions: ICU Delirium, Critical Illness
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 40
Sponsor: Vanderbilt University Medical Center
Location: Vanderbilt University Medical Center Nashville Tennessee
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 \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.
Source: ClinicalTrials.gov (NCT07364162). StuddyBuddy aggregates publicly available trial information.
