Exogenous Lactate Infusion in Traumatic Brain Injury (ELI-TBI)
Status:
Not yet recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
Metabolic crisis is a state of energy insufficiency due to impaired mitochondrial function as
indicated by cerebral microdialysis lactate/pyruvate ratio (LPR). We have performed
preliminary mechanistic analysis of alternative fuels in humans and have demonstrated proof
of concept that exogenous fuels alter brain metabolism. We will conduct a multicenter,
adaptive design-based, proof of concept phase 2 safety study of candidate supplemental fuels
in patients with severe traumatic brain injury to determine safety and efficacy.