Exogenous Ketone Supplementation in ICU Delirium
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ketone monoester
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov