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Metabolic Therapy for Traumatic Brain Injury (MT-TBI)

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ClinicalTrials.gov Identifier: NCT02776488
Recruitment Status : Not yet recruiting
First Posted : May 18, 2016
Last Update Posted : June 26, 2017
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 safety analysis of glucose and sodium lactate infusions in humans and have demonstrated proof of concept that these fuels alter brain metabolism. We will conduct a multicenter, adaptive design-based, proof of concept unblinded phase 2 study of up to 3 candidate supplemental fuels infused over 3 hours in patients with severe traumatic brain injury undergoing standard of care multimodality monitoring with cerebral microdialysis.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Drug: Glucose Drug: Lactate Drug: Beta-hydroxybutyrate Phase 1 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 glucose and 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 all three candidate fuels. We will conduct a multicenter, adaptive design-based, proof of concept unblinded phase 2 study of up to 3 candidate supplemental fuels infused over 3 hours in patients with severe TBI undergoing standard of care multimodality monitoring with cerebral microdialysis. The three candidate fuels are be glucose, sodium lactate, and beta-hydroxybutyrate, with doses to be established in animal models. Infusions will be guided by point of care testing to achieve the ideal blood concentration during the infusion during the infusion.

This is a 5-year safety study using a parallel intervention model with 4 arms, open-label, non-randomized.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Therapy for Traumatic Brain Injury
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Standard of Care
Experimental: Glucose
Infusion of glucose as supplemental fuel (dosage form = solute, dosage to be determined, frequency = 1x, duration = 3hr)
Drug: Glucose
Less than one fifth of one ounce of glucose mixed in standard saline solution will be administered through a standard venous drip line or through the microdialysis catheter as part of standard brain chemistry analyses.

Experimental: Lactate
Infusion of sodium lactate as supplemental fuel (dosage form = solute, dosage TBD, frequency = 1x, duration = 3hr)
Drug: Lactate
Less than two thirds of an ounce of lactate mixed in standard saline solution will be administered through a standard venous drip line or through the microdialysis catheter as part of the standard brain chemistry analyses.
Other Name: Sodium lactate

Experimental: Beta-hydroxybutyrate
Infusion of beta-hydroxybutyrate as supplemental fuel (dosage form = solute, dosage TBD, frequency = 1x, duration = 3hr)
Drug: Beta-hydroxybutyrate
Less than one tenth of one ounce of hydroxybutyrate mixed in standard saline solution will be administered through a standard venous drip line or through the microdialysis catheter as part of the standard brain chemistry analyses.




Primary Outcome Measures :
  1. Normalization of the cerebral microdialysis lactate/pyruvate ratio (LPR) [ Time Frame: 30 days ]
    LPR obtained from measures of fluid through a brain catheter is a marker of metabolic crisis


Secondary Outcome Measures :
  1. Safety endpoints [ Time Frame: 30 days, 6 months, 12 months ]
    Treatment effect at least noninferior to available comparators, using all-cause mortality within each timeframe

  2. Frontal lobe atrophy [ Time Frame: 6 months post injury ]
    Frontal lobe atrophy obtained from brain imaging using magnetic resonance imaging at follow-up visit

  3. Glasgow Outcome Scale - Extended [ Time Frame: 6 months, 12 months ]
    Functional outcome assessment

  4. Mayo-Portland Adaptability Inventory-4 [ Time Frame: 6 months, 12 months ]
    Physical, cognitive, emotional, behavioral, and social assessment

  5. Trail Making Test [ Time Frame: 6 months, 12 months ]
    Assessment of attention and executive ability

  6. Post-traumatic Amnesia Questionnaire [ Time Frame: 6 months, 12 months ]
    Assessment of orientation to person, place and time, and retention of new information

  7. Hooper Visual Organization Test [ Time Frame: 6 months, 12 months ]
    Assessment of visuoperception



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.

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

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
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
United States, California
David Geffen School of Medicine at UCLA Not yet recruiting
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
Principal Investigator: Paul Vespa, MD University of California Los Angeles, Department of Neurosurgery

Publications:

Responsible Party: Paul Vespa, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02776488     History of Changes
Other Study ID Numbers: MT01
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All PHI will be expunged from records before any sharing occurs

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:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System