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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776488
Recruitment Status : Not yet recruiting
First Posted : May 18, 2016
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Vespa, MD, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Drug: Lactate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Dose ranging and then RCT
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Exogenous Lactate Infusion in TBI
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ELI Arm
Infusion of exogenous sodium lactate as supplemental fuel within 48 hours of TBI
Drug: Lactate
Infusion of exogenous lactate
Other Name: Placebo Saline

Placebo Comparator: Placebo
Placebo infusion of normal saline in Part 2 RCT
Drug: Lactate
Infusion of exogenous lactate
Other Name: Placebo Saline




Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    Mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776488


Contacts
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Contact: Courtney Real, BSN RN 310-267-7433 creal@mednet.ucla.edu
Contact: David L McArthur, PhD MPH 310-825-0688 dmca@ucla.edu

Locations
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United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Contact: Steven Cohen, MHA    310-794-1801    steven.cohen@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Paul Vespa, MD University of California Los Angeles, Department of Neurosurgery

Publications:

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Responsible Party: Paul Vespa, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02776488    
Other Study ID Numbers: ELI TBI 1
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All protected health information (PHI) will be expunged from records before any sharing occurs

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Paul Vespa, MD, University of California, Los Angeles:
brain trauma, metabolic therapy
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System