NCT02776488

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Brain Injuries, Traumatic

Interventions

Type	Name	Description
DRUG	Sodium Lactate	Infusion of exogenous sodium lactate
DRUG	Placebo	Infusion of normal saline

Timeline

• Start date: 2020-09-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2016-05-18
• Last updated: 2021-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study