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

University of California, Los Angeles (UCLA)

Status and phase: Withdrawn; Phase 2

Conditions: Brain Injuries, Traumatic

Treatments: Drug: Sodium Lactate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02776488

ELI TBI 1

Details and patient eligibility

About

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.

Full description

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 safety analysis of exogenous sodium lactate infusions in humans and have demonstrated proof of concept that these fuels alter brain metabolism. Animal TBI studies have demonstrated proof of concept for exogenous lactate and pyruvate. We will conduct a multicenter, adaptive design-based, proof of concept biomarker mechanistic safety study of exogenous sodium lactate. The preliminary goal is to determine if exogenous lactate infusion is safe and has a demonstrated effect on selected biomarkers.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

ELI Arm

Experimental group

Description:

Infusion of exogenous sodium lactate as supplemental fuel within 48 hours of TBI

Treatment:

Drug: Sodium Lactate

Placebo

Placebo Comparator group

Description:

Placebo infusion of normal saline in Part 2 RCT

Treatment:

Drug: Placebo