Ketone Supplementation for Intensive Care Unit Delirium

(KETONES-ICU Trial)

Overseen By Rebecca Abel, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanderbilt University Medical Center

Must not be taking: SGLT2 inhibitors, ADH/ALDH inhibitors

Disqualifiers: Type 1 diabetes, Renal failure, Pregnancy, Severe dementia, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

E. Wes Ely, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Ryan J Smith, MD, JD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for ICU patients experiencing delirium, which can cause confusion and hallucinations. Participants must be critically ill with or without ketoacidosis. Specific inclusion and exclusion criteria are not listed but would typically involve factors like age, severity of illness, and other health conditions.

Inclusion Criteria

I can complete mental status exams at the time of joining the study.

I am 18 years or older and admitted to the ICU.

I am currently in the ICU and expected to stay for at least 24 hours.

Exclusion Criteria

Severe metabolic acidosis at enrollment: blood gas pH <7.20 or bicarbonate < 8 mmol/L

Hypoglycemia as an ICU admission diagnosis or glucose <60 mg/dL

Hemoglobin <7.0

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Treatment

Participants receive either the ketone supplement or placebo every six hours for up to 7 days

7 days

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrapure Ketone Monoester

Trial Overview

The study is testing if a medical-grade ketone supplement drink (Ultrapure Ketone Monoester) can safely reduce the occurrence or duration of delirium in ICU patients compared to a placebo that looks and tastes similar but has no active ketones.

How Is the Trial Designed?

Group I: Ketone supplement Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+