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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Drug: Sodium Lactate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dose ranging and then RCT
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ELI Arm<br>Infusion of exogenous sodium lactate as supplemental fuel within 48 hours of TBI | Drug: Sodium Lactate<br>* Infusion of exogenous sodium lactate<br>|
| Placebo Comparator: Placebo<br>Placebo infusion of normal saline in Part 2 RCT | Drug: Placebo<br>* Infusion of normal saline<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality within 30 days | Percentage mortality within 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain trauma, metabolic therapy