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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

May 13, 2016
May 18, 2016
June 26, 2017
October 2017
December 2020   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02776488 on ClinicalTrials.gov Archive Site
  • 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
  • Frontal lobe atrophy [ Time Frame: 6 months post injury ]
    Frontal lobe atrophy obtained from brain imaging using magnetic resonance imaging at follow-up visit
  • Glasgow Outcome Scale - Extended [ Time Frame: 6 months, 12 months ]
    Functional outcome assessment
  • Mayo-Portland Adaptability Inventory-4 [ Time Frame: 6 months, 12 months ]
    Physical, cognitive, emotional, behavioral, and social assessment
  • Trail Making Test [ Time Frame: 6 months, 12 months ]
    Assessment of attention and executive ability
  • Post-traumatic Amnesia Questionnaire [ Time Frame: 6 months, 12 months ]
    Assessment of orientation to person, place and time, and retention of new information
  • Hooper Visual Organization Test [ Time Frame: 6 months, 12 months ]
    Assessment of visuoperception
Same as current
Not Provided
Not Provided
 
Metabolic Therapy for Traumatic Brain Injury
Metabolic Therapy for Traumatic Brain Injury
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Brain Injuries, Traumatic
  • 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.
  • 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
  • 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.
  • 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)
    Intervention: Drug: Glucose
  • Experimental: Lactate
    Infusion of sodium lactate as supplemental fuel (dosage form = solute, dosage TBD, frequency = 1x, duration = 3hr)
    Intervention: Drug: Lactate
  • Experimental: Beta-hydroxybutyrate
    Infusion of beta-hydroxybutyrate as supplemental fuel (dosage form = solute, dosage TBD, frequency = 1x, duration = 3hr)
    Intervention: Drug: Beta-hydroxybutyrate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
170
Same as current
June 2021
December 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Courtney Real, BSN RN 310-267-7433 creal@mednet.ucla.edu
Contact: David L McArthur, PhD MPH 310-825-0688 dmca@ucla.edu
United States
 
 
NCT02776488
MT01
No
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
Plan to Share IPD: No
Plan Description: All PHI will be expunged from records before any sharing occurs
Paul Vespa, MD, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Principal Investigator: Paul Vespa, MD University of California Los Angeles, Department of Neurosurgery
University of California, Los Angeles
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP