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New treatment option for ICU Delirium
Official title Exogenous Ketone Supplementation in ICU Delirium
ClinicalTrials.gov ID: NCT07364162
What this study is testing
What is Ketone monoester?
Ketone monoester is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for icu delirium.
Also referred to as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, D-β-hydroxybutyrate monoester.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (≥18 years old) admitted to the medical intensive care unit.
- Current ICU admission with anticipated ICU stay ≥24 hours.
- Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of...
- Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment.
You likely can't join if
- Severe metabolic acidosis at screening: blood gas pH \<7.20 or bicarbonate \< 8 mmol/L.
- Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state.
- Hypoglycemia as an ICU admission diagnosis or glucose \<60 mg/dL.
- Patients with a history of type 1 diabetes mellitus.
- Hemoglobin \<7.0.
- Fulminant hepatic failure or AST/ALT \> 5× ULN or total bilirubin \> 3 mg/dL.
See the full eligibility criteria
- Adult patients (≥18 years old) admitted to the medical intensive care unit.
- Current ICU admission with anticipated ICU stay ≥24 hours.
- Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of enrollment.
- Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment.
- Severe metabolic acidosis at screening: blood gas pH \<7.20 or bicarbonate \< 8 mmol/L.
- Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state.
- Hypoglycemia as an ICU admission diagnosis or glucose \<60 mg/dL.
- Patients with a history of type 1 diabetes mellitus.
- Hemoglobin \<7.0.
- Fulminant hepatic failure or AST/ALT \> 5× ULN or total bilirubin \> 3 mg/dL.
- Refractory shock (defined as norepinephrine dose ≥20 µg/min or use of a second vasopressor agent).
- Pregnancy (positive urine/serum hCG at screening or known pregnancy).
- Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing.
- SGLT2 inhibitor use within the prior 7 days.
- ADH/ALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned.
- Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE \>4.5, measured using a patient's qualified surrogate. This exclusion...
- 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...
- Active seizures during this ICU admission being treated with intravenous benzodiazepines.
- 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).
- Admission to ICU only for post-operative monitoring or frequent neurologic assessments.
- Incarcerated status.
- Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal.
- Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and/or surrogate refusal.
- Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available.
- Current enrollment in a study that does not allow co-enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.