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NCT07364162 · ClinicalTrials.gov registry record · Phase 2
Exogenous Ketone Supplementation in ICU Delirium
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT07364162: Recruiting Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT07364162 is a Phase 2 study that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07364162, a Phase 2 study, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Delirium severity will be assessed using the Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7) delirium severity scale. The CAM-ICU-7 score ranges from 0 to 7, with higher scores indicating more severe delirium. A composite CAM-ICU-7 delirium severity score will be calculated for each participant by summing all available CAM-ICU-7 scores from enrollment through study day 7. The primary outcome will compare the mean composite CAM-ICU-7 delirium severity score between treatment
Interventions
- DRUG Placebo
- DRUG Ketone monoester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06-09 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT07364162 shows while recruiting
NCT07364162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07364162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07364162 about?
NCT07364162 is a clinical study titled "Exogenous Ketone Supplementation in ICU Delirium". 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 impa...
What is the current status of trial NCT07364162?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2026-06-09. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07364162?
The interventions under investigation include: Placebo (DRUG), Ketone monoester (DRUG).
Who is sponsoring clinical trial NCT07364162?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07364162's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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