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

NCT ID: NCT02776488

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2026-06-30

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.

Conditions

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Brain Injuries, Traumatic

Keywords

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brain trauma, metabolic therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dose ranging and then RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ELI Arm

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

Group Type EXPERIMENTAL

Sodium Lactate

Intervention Type DRUG

Infusion of exogenous sodium lactate

Placebo

Placebo infusion of normal saline in Part 2 RCT

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Infusion of normal saline

Interventions

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Sodium Lactate

Infusion of exogenous sodium lactate

Intervention Type DRUG

Placebo

Infusion of normal saline

Intervention Type DRUG

Other Intervention Names

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Normal saline

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Paul Vespa, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Vespa, MD

Role: PRINCIPAL_INVESTIGATOR

University of California Los Angeles, Department of Neurosurgery

Locations

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David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Glenn TC, Martin NA, Horning MA, McArthur DL, Hovda DA, Vespa P, Brooks GA. Lactate: brain fuel in human traumatic brain injury: a comparison with normal healthy control subjects. J Neurotrauma. 2015 Jun 1;32(11):820-32. doi: 10.1089/neu.2014.3483. Epub 2015 Mar 31.

Reference Type BACKGROUND
PMID: 25594628 (View on PubMed)

Glenn TC, Martin NA, McArthur DL, Hovda DA, Vespa P, Johnson ML, Horning MA, Brooks GA. Endogenous Nutritive Support after Traumatic Brain Injury: Peripheral Lactate Production for Glucose Supply via Gluconeogenesis. J Neurotrauma. 2015 Jun 1;32(11):811-9. doi: 10.1089/neu.2014.3482. Epub 2015 Mar 11.

Reference Type BACKGROUND
PMID: 25279664 (View on PubMed)

Vespa P, McArthur DL, Stein N, Huang SC, Shao W, Filippou M, Etchepare M, Glenn T, Hovda DA. Tight glycemic control increases metabolic distress in traumatic brain injury: a randomized controlled within-subjects trial. Crit Care Med. 2012 Jun;40(6):1923-9. doi: 10.1097/CCM.0b013e31824e0fcc.

Reference Type BACKGROUND
PMID: 22610193 (View on PubMed)

Vespa P, Bergsneider M, Hattori N, Wu HM, Huang SC, Martin NA, Glenn TC, McArthur DL, Hovda DA. Metabolic crisis without brain ischemia is common after traumatic brain injury: a combined microdialysis and positron emission tomography study. J Cereb Blood Flow Metab. 2005 Jun;25(6):763-74. doi: 10.1038/sj.jcbfm.9600073.

Reference Type BACKGROUND
PMID: 15716852 (View on PubMed)

Vespa P, Tubi M, Claassen J, Buitrago-Blanco M, McArthur D, Velazquez AG, Tu B, Prins M, Nuwer M. Metabolic crisis occurs with seizures and periodic discharges after brain trauma. Ann Neurol. 2016 Apr;79(4):579-90. doi: 10.1002/ana.24606. Epub 2016 Feb 28.

Reference Type BACKGROUND
PMID: 26814699 (View on PubMed)

Xu Y, McArthur DL, Alger JR, Etchepare M, Hovda DA, Glenn TC, Huang S, Dinov I, Vespa PM. Early nonischemic oxidative metabolic dysfunction leads to chronic brain atrophy in traumatic brain injury. J Cereb Blood Flow Metab. 2010 Apr;30(4):883-94. doi: 10.1038/jcbfm.2009.263. Epub 2009 Dec 23.

Reference Type BACKGROUND
PMID: 20029449 (View on PubMed)

Bouzat P, Magistretti PJ, Oddo M. Hypertonic lactate and the injured brain: facts and the potential for positive clinical implications. Intensive Care Med. 2014 Jun;40(6):920-1. doi: 10.1007/s00134-014-3312-x. Epub 2014 May 1. No abstract available.

Reference Type BACKGROUND
PMID: 24789621 (View on PubMed)

Bouzat P, Sala N, Suys T, Zerlauth JB, Marques-Vidal P, Feihl F, Bloch J, Messerer M, Levivier M, Meuli R, Magistretti PJ, Oddo M. Cerebral metabolic effects of exogenous lactate supplementation on the injured human brain. Intensive Care Med. 2014 Mar;40(3):412-21. doi: 10.1007/s00134-013-3203-6. Epub 2014 Jan 30.

Reference Type BACKGROUND
PMID: 24477453 (View on PubMed)

Vespa P, Wolahan S, Buitrago-Blanco M, Real C, Ruiz-Tejeda J, McArthur DL, Chiang JN, Agoston D, Glenn TC. Exogenous lactate infusion (ELI) in traumatic brain injury: higher dose is better? Crit Care. 2025 Apr 14;29(1):153. doi: 10.1186/s13054-025-05374-y.

Reference Type DERIVED
PMID: 40229764 (View on PubMed)

Other Identifiers

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ELI TBI 1

Identifier Type: -

Identifier Source: org_study_id