Clinical Trial

Exogenous Ketone Supplementation in ICU Delirium

Study acronym: KETONES-ICU
Recruiting Phase 2
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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.
Protocol Amendment History 3 changes
critical Phase changed: Phase 1 -> Phase 2 2026-06-16
critical Recruitment opened 2026-06-12
critical Primary endpoint(s) modified 2026-06-10
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 2026-06-15