Dr Robert McNamara
Feasibility Randomised Controlled Trial of Enteric R-1,3-Butanediol in Moderate to Severe Traumatic Brain Injury with a Nested Dosing Study
East Metropolitan Health Service
Funding: $99,350
Coordinating Principal Investigator: Dr Robert McNamara
Co-Investigators: Miss Jessical Polenz-Shaw, Professor Andrew Udy, Professor Mark Plummer, Associate Professor Neha Haul, Dr Kyle White, Associate Professor Yasmine Ali Abdelhamid
Associate Investigators: Miss Trisha Hardman, Miss Sharon Waterson,
This study is testing whether a ketone-containing drink can be safely and effectively used in patients with moderate to severe traumatic brain injury in intensive care. Ketones provide an alternative energy source that the injured brain can use when normal pathways are disrupted.
In Phase 1, dosing schedules will be tested in 12 ICU patients at Royal Perth Hospital to identify the safest way to keep ketone levels in the target range. In Phase 2, 30 patients across multiple trauma centres will be randomised to receive either the optimal ketone dose or standard nutrition.
The aim is to confirm safety, feasibility and dosing, while capturing early signals of benefit. If successful, this approach could pave the way for a simple new therapy to improve recovery after brain injury. This foundational work will inform future definitive efficacy trials.