Ketone Supplement for ICU Delirium Study
This study is looking at whether an investigational medical-grade ketone supplement called Ketone monoester can help reduce or shorten delirium in patients in the intensive care unit (ICU). Delirium is when you suddenly feel confused, have trouble thinking clearly, or see and hear things that aren't real. We want to see if Ketone monoester is safe and practical to use, and if it might improve delirium compared to a placebo (a look-alike liquid with no active medicine). You might be able to join if you are an adult (18 or older) in the medical ICU with an expected stay of at least 24 hours, and can receive liquids through your mouth or a feeding tube. We will measure your delirium severity score to see if the treatment helps.
- Study design
- This is an interventional study planning to enroll 40 participants. Participants will receive either Ketone monoester or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your delirium severity will be measured from when you join the study through study day 7.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Exogenous Ketone Supplementation in ICU Delirium
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- E. Wes Ely, MD, MPH · STUDY_DIRECTOR · Vanderbilt University Medical Center
- Ryan J Smith, MD, JD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Mean composite Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7) delirium severity scoreFrom enrollment through study day 7.
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 arms. A clinically meaningful treatment effect is defined as a 25% lower mean composite CAM-ICU-7 score in the intervention arm compared with the control arm.