WithdrawnPhase 2

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

Stopped: The manufacturer of sodium lactate has stopped making the medication

United States0Started 2020-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mortality within 30 days

Timeframe: 30 days

Trial details

NCT IDNCT02776488

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

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