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Ketamine in Severe Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury, Traumatic Encephalopathy

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring ketamine, traumatic brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Severe traumatic brain injury Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation Age greater than or equal to 18 years Exclusion Criteria: Documented allergy to ketamine Sinus tachycardia with sustained heart rate >120 Any episode of non-sinus tachycardia Documented history of schizophrenia Systolic blood pressure > 180, diastolic blood pressure > 120 Documented episode(s) of ICP elevations >25 mm Hg sustained greater than 5 minutes within 24 hours Similar episodes as above of PbtO2 <15 mmHg Positive pregnancy test and/or is currently breast-feeding

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Intracranial Pressure
    Measurement of pressure within the rigid skill, with values greater than 22 mm Hg sustained proven to be injurious in patients with traumatic brain injury
    Brain tissue oxygenation
    Measurement of the concentration of oxygen within the brain tissue, with values less than 20 mmHg sustained proven to be injurious in patients with traumatic brain injury

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 25, 2023
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06062628
    Brief Title
    Ketamine in Severe Traumatic Brain Injury
    Official Title
    Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Traumatic brain injury (TBI) accounts for approximately 2.5 million visits to emergency departments in the United States each year. After decades of research, management strategies for severe TBI (sTBI) patients are still evolving. Optimizing intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are paramount in the management of these patients and placement of these monitors is the current standard-of-care. However, monitoring brain oxygenation (PbtO2) with invasive intraparenchymal monitors is currently under investigation in the management of severe TBI and placement of these monitors is gaining widespread use. This has opened the door for the use of tiered therapy to optimize ICP and PbtO2 simultaneously. Current evidence indicates that correction of ICP, CPP and PbtO2 in sTBI requires optimized analgesia and sedation. Ketamine is one of the few drugs available that has both sedative and analgesic properties and does not commonly compromise respiratory drive like opioids and sedative-hypnotics. However, traditionally, ketamine has been viewed as contraindicated in the setting of TBI due to concerns for elevation in ICP. Yet, new data has cast this long-held assumption into significant doubt. Hence the present pilot study will characterize the neurophysiological response to a single dose of ketamine in critically-ill TBI patient with ICP and PbtO2 monitoring.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury, Traumatic Encephalopathy
    Keywords
    ketamine, traumatic brain injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine Hydrochloride
    Intervention Description
    Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation
    Primary Outcome Measure Information:
    Title
    Intracranial Pressure
    Description
    Measurement of pressure within the rigid skill, with values greater than 22 mm Hg sustained proven to be injurious in patients with traumatic brain injury
    Time Frame
    3 hours
    Title
    Brain tissue oxygenation
    Description
    Measurement of the concentration of oxygen within the brain tissue, with values less than 20 mmHg sustained proven to be injurious in patients with traumatic brain injury
    Time Frame
    3 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Severe traumatic brain injury Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation Age greater than or equal to 18 years Exclusion Criteria: Documented allergy to ketamine Sinus tachycardia with sustained heart rate >120 Any episode of non-sinus tachycardia Documented history of schizophrenia Systolic blood pressure > 180, diastolic blood pressure > 120 Documented episode(s) of ICP elevations >25 mm Hg sustained greater than 5 minutes within 24 hours Similar episodes as above of PbtO2 <15 mmHg Positive pregnancy test and/or is currently breast-feeding

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ketamine in Severe Traumatic Brain Injury

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