Metabolic Therapy for Traumatic Brain Injury (MT-TBI)
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| ClinicalTrials.gov Identifier: NCT02776488 |
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Recruitment Status :
Not yet recruiting
First Posted : May 18, 2016
Last Update Posted : June 26, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Injuries, Traumatic | Drug: Glucose Drug: Lactate Drug: Beta-hydroxybutyrate | Phase 1 Phase 2 |
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 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control
Standard of Care
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Experimental: Glucose
Infusion of glucose as supplemental fuel (dosage form = solute, dosage to be determined, frequency = 1x, duration = 3hr)
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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. |
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Experimental: Lactate
Infusion of sodium lactate as supplemental fuel (dosage form = solute, dosage TBD, frequency = 1x, duration = 3hr)
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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 |
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Experimental: Beta-hydroxybutyrate
Infusion of beta-hydroxybutyrate as supplemental fuel (dosage form = solute, dosage TBD, frequency = 1x, duration = 3hr)
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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. |
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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, 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 | |
| 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:
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brain trauma, metabolic therapy |
Additional relevant MeSH terms:
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Wounds and Injuries Brain Injuries Brain Injuries, Traumatic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |