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ICU DeliriumPhase 2KETONES-ICUNCT07364162

Exogenous Ketone Supplementation in ICU Delirium

A Phase 2 study testing Ketone monoester in people with ICU Delirium and Critical Illness, run by Vanderbilt University Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ICU Delirium, Critical Illness
What is being tested?
Ketone monoester
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
9 Jun 2026to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 International Normalized Ratio (INR) > 3, when not attributable to therapeutic anticoagulation or another clearly non-hepatic cause.
Show all 20Show fewer
  • Refractory shock, defined as a sustained norepinephrine requirement ≥30 µg/min, or norepinephrine-equivalent vasopressor dose, despite appropriate resuscitation, or ongoing escalation of vasopressor support at the time of enrollment.
  • Pregnancy (positive urine/serum hCG at screening or known pregnancy) or breastfeeding.
  • Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing.
  • 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. This exclusion also pertains to mental illnesses requiring long-term institutionalization, acquired or congenital intellectual disability, severe neuromuscular disorders, Parkinson's disease, and Huntington's disease. It also excludes patients with severe deficits due to structural brain diseases such as stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema.
  • 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 intravenous boluses) for this dependency.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan J Smith, MD, JD contact

(602) 538-5003

ryan.j.smith@vumc.org

Rebecca Abel, MA contact

6158753763

wes.ely@vumc.org

United States1 site, 1 recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Ryan J Smith, MD, JD, +1 (602) 5385003, ryan.j.smith@vumc.org

    Recruiting

Other trials in United States

About this study

Official title: Exogenous Ketone Ester Supplementation in ICU Delirium (KETONES ICU)

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.

Read the detailed description

Delirium is a prevalent neuropsychiatric syndrome characterized by an acute disturbance in attention, cognition, and consciousness. It is associated with significant morbidity, mortality, and healthcare expenditures. Recent research has provided evidence supporting the connection between brain metabolism and delirium. During states of increased systemic inflammation, such as sepsis or trauma, the brain experiences a mismatch between energy supply and demand, which is commonly associated with delirium, especially in those with preexisting cognitive impairment.

In critically ill patients, mitochondrial dysfunction occurs in the setting of systemic inflammation, contributing to increased blood-brain barrier permeability and neuroinflammation. The downstream consequence of this is microglial activation, which amplifies the inflammatory response through the release of pro-inflammatory cytokines. The resultant mitochondrial dysfunction leads to impaired oxidative phosphorylation, decreased adenosine triphosphate (ATP) production, and increased reactive oxygen species production. In response to systemic inflammation, microglia transition to a pro-inflammatory phenotype characterized by increased aerobic glycolysis. This metabolic reprogramming depletes glucose availability for neurons and exacerbates the cerebral energy deficit. Emerging evidence suggests that activated microglia compete with neurons for metabolic substrates during inflammation. Activated microglia exhibit metabolic flexibility, shifting toward increased glycolysis to meet their heightened energy and biosynthetic demands. This competition for nutrients exacerbates the neuronal energy deficit and increases metabolic stress. The investigators hypothesize that this brain energy deficit contributes to the cognitive and neurological symptoms characteristic of delirium.

Ketones, such as β-hydroxybutyrate, are the brain's secondary source of energy when glucose is not available. After transport across the blood-brain barrier, β-hydroxybutyrate is metabolized to acetyl-CoA (acetyl coenzyme A), thereby directly entering the tricarboxylic acid cycle, bypassing the glycolytic bottleneck, to produce ATP. In addition to serving as a substrate for ATP production, ketones support mitochondrial function, limit oxidative stress, and reduce neuroinflammation. Ketones confer a two-fold therapeutic advantage in the setting of nutrient competition. Not only do they support neuronal oxidative phosphorylation by bypassing impaired glycolysis, but they also promote anti-inflammatory microglial phenotypes, inhibit inflammasome activation, and support metabolic reprogramming. This dual effect further reduces microglial glucose demand, enhancing neuronal substrate availability.

The investigators propose a prospective, randomized, placebo-controlled pilot study of exogenous ketone ester supplement administration in 40 critically ill patients to assess the safety and feasibility of this novel intervention and to generate preliminary data on its efficacy in reducing ICU delirium, as measured by delirium and coma free days (DCFDs). Exogenous ketones have been shown to support brain energetics and reduce neuroinflammation, directly targeting pathways implicated in the development of delirium. By reducing the duration of delirium or preventing its onset, this research has the potential to improve long-term cognitive outcomes for ICU survivors. The investigators propose enrolling adult patients at the time of ICU admission, with randomization to either an enteral ketone ester treatment group or a taste, volume, and calorie-matched dextrose-containing placebo. The study drug or placebo will be administered at the time of enrollment, within 24 hours of ICU admission, and every six hours thereafter for up to 7 days until ICU discharge, or death, whichever occurs first. Ketone administration will be continued after the diagnosis of delirium. In accordance with prior studies, the initial dose of β-hydroxybutyrate will be 25 g; however, subsequent doses will be titrated to maintain serum β-hydroxybutyrate levels between 1.5 and 3.5 mM, with protocolized monitoring of vital signs, serum pH, glucose levels, and adverse gastrointestinal effects. Delirium will be assessed using the Confusion Assessment Method for the ICU (CAM-ICU) delirium screening tool twice daily for a period of 7 days.

This pilot study will assess the feasibility, safety, and tolerability of oral exogenous ketone supplementation in critically ill patients. The goal is to demonstrate that ketone administration is well-tolerated, with no significant safety concerns, consistent with prior evidence that oral ketones can be administered safely, even in vulnerable patient populations. Successful completion of this aim will establish a safety profile for ketone use in the ICU, which is essential before adopting this novel therapy for critically ill patients. The investigators hypothesize that patients receiving ketones will have more DCFDs compared to those receiving a placebo. The investigators will also perform an exploratory analysis of the biological impact of ketone therapy by examining biomarkers associated with delirium and ketone metabolism through serial measurement of serum levels of peripheral inflammatory mediators, metabolic stress assays, β-hydroxybutyrate levels, and markers of central nervous system (CNS) injury.

Ketones offer a promising novel therapeutic option for delirium. By targeting the underlying neurometabolic and neuroinflammatory changes associated with delirium, they support energy production, decrease oxidative stress, and modulate inflammation. Patients with preexisting cognitive impairment, such as those with mild cognitive impairment or Alzheimer's dementia, exhibit a baseline brain energy gap due to impaired cerebral glucose metabolism. This chronic energy deficit increases the vulnerability of the aging brain to delirium. Furthermore, the neurometabolic consequences of delirium in those with preexisting cognitive impairment exacerbate the brain energy gap, accelerating cognitive decline. The safety, tolerability, and rapid induction of ketosis following oral administration of ketone esters, in addition to the aforementioned beneficial effects, suggest this may be a therapy that could be initiated upon ICU admission as a potential preventative measure in those patients at risk. Ketones have the potential to transform delirium management and improve patient care; however, this clinical trial is required to evaluate the safety and efficacy of oral ketone ester supplementation in reducing the incidence, severity, and duration of delirium in critically ill patients.

Being tested
Ketone monoester, Placebo
Keywords
ICU, Intensive Care Unit, Critical care, Critical illness, Ketones
Medical subject headings
Critical Illness, Ketosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketone monoesterDrug

    Also called (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, D-β-hydroxybutyrate monoester, D-BHB monoester, (R)-hydroxybutyl (R)-3-hydroxybutyrate;

    Ketone monoester diluted to a total volume of 74 mL with water and administered enterally (oral/feeding tube). Dosing is protocolized with an initial dose of 25 g and subsequent dose titration based on serum β-hydroxybutyrate levels to target a prespecified serum β-hydroxybutyrate range, administered every 6 hours for up to 7 days (or ICU discharge or death, whichever occurs first).

  • PlaceboDrug

    Placebo consists of 74 mL of dextrose 50% in water (D50W) plus 50 mg sucrose octaacetate for taste matching; administered enterally (oral/feeding tube) on the same schedule as the experimental arm.

Study groups in NCT07364162
Study groupRoleWhat they receive
Ketone monoesterExperimentalNot described
Receives: Drug: Ketone monoester
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean composite Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7) delirium severity score

    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.

    Measured: From enrollment through study day 7.

Secondary outcomes (7)

  1. Feasibility: Proportion of participants achieving target peak serum β-hydroxybutyrate (1.5-3.5 mmol/L) on at least 50% of dosing days

    Peak serum β-hydroxybutyrate will be measured once daily using a post-dose blood draw collected 60-90 minutes after the morning ketone dose. A dosing day will be considered evaluable if a valid post-dose serum β-hydroxybutyrate measurement is obtained. A dosing day will be considered within target range if the post-dose serum β-hydroxybutyrate concentration is 1.5-3.5 mmol/L. This feasibility outcome is the proportion of ketone-group participants with post-dose serum β-hydroxybutyrate within the target range on at least 50% of evaluable dosing days. Feasibility will be considered met if at least 70% of ketone-group participants meet this criterion.

    Measured: From enrollment through study day 7 or ICU discharge.

  2. Feasibility: Proportion of scheduled post-dose serum β-hydroxybutyrate draws completed

    The proportion of scheduled daily post-dose serum β-hydroxybutyrate draws that are successfully collected during the dosing period will be calculated and summarized. Feasibility performance will be summarized relative to a target of ≥80% completion.

    Measured: From enrollment through study day 7 or ICU discharge.

  3. Feasibility: Proportion of post-dose serum β-hydroxybutyrate measurements >4.0 mmol/L

    In participants assigned to the ketone group, the proportion of valid daily post-dose serum β-hydroxybutyrate measurements greater than 4.0 mmol/L will be calculated during the dosing period. Performance will be summarized relative to a target of fewer than 10% of post-dose measurements greater than 4.0 mmol/L.

    Measured: From enrollment through study day 7 or ICU discharge.

  4. Safety and tolerability: Number of participants with ≥1 prespecified safety or tolerability event

    A prespecified safety or tolerability event is defined as any of the following occurring from enrollment through study day 7: acid-base abnormality (blood gas pH <7.20 or serum bicarbonate <8 mmol/L), off-target hyperketonemia (peak serum β-hydroxybutyrate >3.5 mmol/L despite dose reduction), hypoglycemia (<60 mg/dL), renal or hepatic safety signal (new dialysis initiation; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5× upper limit of normal, or total bilirubin >3 mg/dL without alternative explanation), or hemodynamic instability temporally related to dosing. Gastrointestinal symptoms (nausea, vomiting, diarrhea, cramping) will be reported separately as tolerability adverse events. The outcome will be summarized as the proportion of participants with ≥1 prespecified event by treatment arm.

    Measured: From enrollment through study day 7.

  5. Feasibility: Adherence to ketone dose-titration algorithm

    In those participants assigned to the treatment group, adherence will be defined as the proportion of dosing decisions during the dosing period that follow the prespecified dose-titration algorithm based on post-dose serum β-hydroxybutyrate results and protocol-defined dose adjustment rules. Adherence will be summarized relative to a target of ≥80%.

    Measured: From enrollment through study day 7 or ICU discharge.

  6. Delirium- and coma-free days (DCFDs) through study day 7

    Delirium- and coma-free days (DCFDs) is defined as the number of days from enrollment through study day 7 during which participants are alive and free of both delirium and coma. Delirium is defined as any positive assessment on the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) administered twice daily while participants remain in the intensive care unit. Coma is defined as a Richmond Agitation-Sedation Scale score of -4 or -5, or an equivalent protocol-defined coma assessment. Days after ICU discharge will be counted as delirium- and coma-free if the participant is alive. Days after death will be counted as not delirium- and coma-free. Delirium- and coma-free days will be summarized by treatment arm.

    Measured: From enrollment through study day 7.

  7. Peak serum beta-hydroxybutyrate concentration following dosing

    Post-dose serum β-hydroxybutyrate concentration will be measured once daily using a blood draw collected 60-90 minutes after the morning dose. For each participant, the mean post-dose serum β-hydroxybutyrate concentration during the dosing period will be calculated and reported in mmol/L by treatment arm.

    Measured: From enrollment through study day 7 or ICU discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start9 Jun 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364162
Sponsor's protocol ID
U16370
Acronym
KETONES-ICU
Status last verified
Aug 2026
First submitted
9 Jan 2026
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) for all randomized participants that underlie reported results, including: baseline demographics and clinical characteristics; eligibility variables; treatment assignment and dosing history; serum β-hydroxybutyrate and other protocol safety labs (e.g., glucose, acid-base measures); delirium/coma assessments (CAM-ICU, CAM-ICU-7) and derived delirium- and coma-free days through study day 7; key clinical outcomes (e.g., ICU/hospital length of stay, mortality); adverse events, dose holds/reductions/discontinuations; and research biomarker assay results. A data dictionary will be provided. Direct identifiers and free-text clinical notes will not be shared.

Publications

  • Smith R, Harrison F, Bastarache J, Williams Roberson S, Zaganjor E, Pandharipande P, Rice T, Ely W. Potential therapeutic benefit of exogenous ketone ester administration in delirium: a narrative review. Crit Care. 2025 Oct 7;29(1):424. doi: 10.1186/s13054-025-05680-5.

    PubMed 41057929

  • Girard TD, Exline MC, Carson SS, Hough CL, Rock P, Gong MN, Douglas IS, Malhotra A, Owens RL, Feinstein DJ, Khan B, Pisani MA, Hyzy RC, Schmidt GA, Schweickert WD, Hite RD, Bowton DL, Masica AL, Thompson JL, Chandrasekhar R, Pun BT, Strength C, Boehm LM, Jackson JC, Pandharipande PP, Brummel NE, Hughes CG, Patel MB, Stollings JL, Bernard GR, Dittus RS, Ely EW; MIND-USA Investigators. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness. N Engl J Med. 2018 Dec 27;379(26):2506-2516. doi: 10.1056/NEJMoa1808217. Epub 2018 Oct 22.

    PubMed 30346242

  • Saris CGJ, Timmers S. Ketogenic diets and Ketone suplementation: A strategy for therapeutic intervention. Front Nutr. 2022 Nov 15;9:947567. doi: 10.3389/fnut.2022.947567. eCollection 2022.

    PubMed 36458166

  • Hou L, Yang J, Li S, Huang R, Zhang D, Zhao J, Wang Q. Glibenclamide attenuates 2,5-hexanedione-induced neurotoxicity in the spinal cord of rats through mitigation of NLRP3 inflammasome activation, neuroinflammation and oxidative stress. Toxicol Lett. 2020 Oct 1;331:152-158. doi: 10.1016/j.toxlet.2020.06.002. Epub 2020 Jun 6.

    PubMed 32522579

  • Oh U, Woolbright E, Lehner-Gulotta D, Coleman R, Conaway M, Goldman MD, Brenton JN. Serum neurofilament light chain in relapsing multiple sclerosis patients on a ketogenic diet. Mult Scler Relat Disord. 2023 May;73:104670. doi: 10.1016/j.msard.2023.104670. Epub 2023 Mar 25.

    PubMed 36996634

  • Bock M, Steffen F, Zipp F, Bittner S. Impact of Dietary Intervention on Serum Neurofilament Light Chain in Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2021 Nov 11;9(1):e1102. doi: 10.1212/NXI.0000000000001102. Print 2022 Jan.

    PubMed 34764215

  • McDougall A, Bayley M, Munce SE. The ketogenic diet as a treatment for traumatic brain injury: a scoping review. Brain Inj. 2018;32(4):416-422. doi: 10.1080/02699052.2018.1429025. Epub 2018 Jan 23.

    PubMed 29359959

  • Youm YH, Nguyen KY, Grant RW, Goldberg EL, Bodogai M, Kim D, D'Agostino D, Planavsky N, Lupfer C, Kanneganti TD, Kang S, Horvath TL, Fahmy TM, Crawford PA, Biragyn A, Alnemri E, Dixit VD. The ketone metabolite beta-hydroxybutyrate blocks NLRP3 inflammasome-mediated inflammatory disease. Nat Med. 2015 Mar;21(3):263-9. doi: 10.1038/nm.3804. Epub 2015 Feb 16.

    PubMed 25686106

  • Prins M, Greco T, Alexander D, Giza CC. The pathophysiology of traumatic brain injury at a glance. Dis Model Mech. 2013 Nov;6(6):1307-15. doi: 10.1242/dmm.011585. Epub 2013 Sep 12.

    PubMed 24046353

  • Xu Q, Zhang Y, Zhang X, Liu L, Zhou B, Mo R, Li Y, Li H, Li F, Tao Y, Liu Y, Xue C. Medium-chain triglycerides improved cognition and lipid metabolomics in mild to moderate Alzheimer's disease patients with APOE4-/-: A double-blind, randomized, placebo-controlled crossover trial. Clin Nutr. 2020 Jul;39(7):2092-2105. doi: 10.1016/j.clnu.2019.10.017. Epub 2019 Oct 22.

    PubMed 31694759

  • Ota M, Matsuo J, Ishida I, Takano H, Yokoi Y, Hori H, Yoshida S, Ashida K, Nakamura K, Takahashi T, Kunugi H. Effects of a medium-chain triglyceride-based ketogenic formula on cognitive function in patients with mild-to-moderate Alzheimer's disease. Neurosci Lett. 2019 Jan 18;690:232-236. doi: 10.1016/j.neulet.2018.10.048. Epub 2018 Oct 24.

    PubMed 30367958

  • Jensen NJ, Nilsson M, Ingerslev JS, Olsen DA, Fenger M, Svart M, Moller N, Zander M, Miskowiak KW, Rungby J. Effects of beta-hydroxybutyrate on cognition in patients with type 2 diabetes. Eur J Endocrinol. 2020 Feb;182(2):233-242. doi: 10.1530/EJE-19-0710.

    PubMed 31821157

  • Fortier M, Castellano CA, Croteau E, Langlois F, Bocti C, St-Pierre V, Vandenberghe C, Bernier M, Roy M, Descoteaux M, Whittingstall K, Lepage M, Turcotte EE, Fulop T, Cunnane SC. A ketogenic drink improves brain energy and some measures of cognition in mild cognitive impairment. Alzheimers Dement. 2019 May;15(5):625-634. doi: 10.1016/j.jalz.2018.12.017. Epub 2019 Apr 23.

    PubMed 31027873

  • Fortier M, Castellano CA, St-Pierre V, Myette-Cote E, Langlois F, Roy M, Morin MC, Bocti C, Fulop T, Godin JP, Delannoy C, Cuenoud B, Cunnane SC. A ketogenic drink improves cognition in mild cognitive impairment: Results of a 6-month RCT. Alzheimers Dement. 2021 Mar;17(3):543-552. doi: 10.1002/alz.12206. Epub 2020 Oct 26.

    PubMed 33103819

  • Cunnane S, Nugent S, Roy M, Courchesne-Loyer A, Croteau E, Tremblay S, Castellano A, Pifferi F, Bocti C, Paquet N, Begdouri H, Bentourkia M, Turcotte E, Allard M, Barberger-Gateau P, Fulop T, Rapoport SI. Brain fuel metabolism, aging, and Alzheimer's disease. Nutrition. 2011 Jan;27(1):3-20. doi: 10.1016/j.nut.2010.07.021. Epub 2010 Oct 29.

    PubMed 21035308

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ketone monoester in people with ICU Delirium and Critical Illness, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryan J Smith, MD, JD ((602) 538-5003, ryan.j.smith@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean composite Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7) delirium severity score (time frame: From enrollment through study day 7.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07364162, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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