Exogenous Lactate Infusion in Traumatic Brain Injury (ELI-TBI)

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles

Criteria

Inclusion Criteria:

• Adult patients seen in the Medical Center Emergency Department

• Adult patients transferred to the Neurocritical Intensive Care Unit with a physician's diagnosis of brain injury.

• GCS 3-12

Exclusion Criteria:

• Pregnancy at time of injury

• History of diabetes mellitus

• History of hemodynamic instability

• Known terminal illness which alters brain functioning

• Diagnosed AIDS progressed to AIDS dementia

• Known history of chronic severe neurological disturbance

• Severe retardation

• Previous severe diminished mental capacity

• No command of either English or Spanish

• Arrest for a felony

• Active neurologic condition such as stroke, recent TBI

• metabolic disorder

• preexisting hyperlactatemia

• instability precluding experimental intervention