Ketone Supplementation for Intensive Care Unit Delirium

(KETONES-ICU Trial)

This trial explores whether a special ketone supplement drink, called Ultrapure Ketone Monoester, can reduce delirium in ICU patients. Delirium can cause confusion and hallucinations, often leading to long-term issues like memory problems and depression. The trial compares the effects of the ketone drink to a placebo (a non-active lookalike drink) to assess its safety and effectiveness. Patients in the ICU for at least 24 hours who can take the supplement by mouth or feeding tube might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

The trial does not specify if you need to stop all current medications, but you cannot participate if you've used SGLT2 inhibitors or ADH/ALDH inhibitors in the past 7 days. It's best to discuss your specific medications with the trial team.

Research shows that the investigational ketone supplement, Ultrapure Ketone Monoester, is currently being tested for safety in ICU patients. Although limited data from human studies exist, this trial is in an early stage, focusing primarily on how well people tolerate the supplement. Early trials like this one closely monitor for any negative reactions to ensure safety for broader use later.

Unlike the standard treatments for ICU delirium, which typically include antipsychotics and sedatives, the new approach with Ultrapure Ketone Monoester focuses on boosting brain energy metabolism. Researchers are excited about this treatment because ketones serve as an alternative energy source for the brain, potentially reducing inflammation and improving mental clarity. This novel mechanism of action could offer faster and safer relief from delirium symptoms without the side effects commonly associated with traditional medications.

This trial will compare the effects of a ketone supplement with a placebo in addressing ICU delirium. Research has shown that ketone supplements might help with ICU delirium by altering the brain's energy source. Early findings suggest that ketones could enhance brain function by providing an alternative energy source. Studies have shown that delirium in ICU patients can lead to longer hospital stays and worse long-term outcomes. Although specific data on ketone supplements' effects on delirium is limited, researchers believe they might reduce or shorten its duration. This belief is based on the idea that a better energy supply to the brain could lead to clearer thinking and less confusion.¹²⁴⁶⁷