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INTREPID: Impact of Fever Prevention in Brain Injured Patients

Sponsor
C. R. Bard (Industry)
Overall Status
Terminated
CT.gov ID
NCT02996266
Collaborator
Yale University (Other), Boston University (Other)
686
Enrollment
40
Locations
2
Arms
64.3
Actual Duration (Months)
17.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.

Condition or Disease Intervention/Treatment Phase
  • Device: Targeted Temperature Management
  • Other: Standard Care
 N/A

Detailed Description

Multiple studies demonstrate that fever / elevated temperature is associated with poor outcomes in brain injured patients; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. This study will be conducted to assess the impact of advanced temperature control to prevent fever in brain injured patients. The fever prevention group will use the Arctic Sun Temperature Management System and will be compared to standard care patients in whom fever may spontaneously develop. If fever develops in a patient in the standard care group, they will be treated with standard fever care measures according to a step-wise algorithm, consisting primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when necessary, advanced targeted temperature management devices.

Study Design

Study Type:
Interventional
Actual Enrollment :
686 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Fever Prevention in Brain Injured Patients
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
May 12, 2022
Actual Study Completion Date :
May 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fever Prevention

Fever will be prevented using a surface targeted temperature management system

Device: Targeted Temperature Management
Prophylactic normothermia
Other Names:
  • Arctic Sun 5000 Temperature Management System

    		•
    Active Comparator: Standard Care

    Standard care in which fever may spontaneously develop

    Other: Standard Care
    No intervention to control temperature unless fever occurs

    Outcome Measures

    Primary Outcome Measures

    1. Fever Burden [Up to 14 days]

      Daily average fever burden (°C-hour)

    Secondary Outcome Measures

    1. Primary Neurologic Outcome: Short-Term [3-months post injury]

      Modified Rankin Scale

    2. Other Neurologic Outcomes: NIH Stroke Scale Short-Term [3-months post injury]

      NIH Stroke Scale

    3. Other Neurologic Outcomes: Barthel Index Short-Term [3-months post injury]

      Barthel Index

    4. Other Neurologic Outcomes: Glasgow Outcome Scale Short-Term [3-months post injury]

      Glasgow Outcome Scale

    5. Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term [3-months post injury]

      Montreal Cognitive Assessment

    6. Primary Neurologic Outcome: Mid-Term [6-months post injury]

      Modified Rankin Scale

    7. Other Neurologic Outcomes: NIH Stroke Scale Mid-Term [6-months post injury]

      NIH Stroke Scale

    8. Other Neurologic Outcomes: Barthel Index Mid-Term [6-months post injury]

      Barthel Index

    9. Other Neurologic Outcomes: Glasgow Outcome Scale Mid-Term [6-months post injury]

      Glasgow Outcome Scale

    10. Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term [6-months post injury]

      Montreal Cognitive Assessment

    11. Primary Neurologic Outcome: Long-Term [12-months post injury]

      Modified Rankin Scale

    12. Adverse Events [From date of randomization until hospital discharge, assessed up to 30 days]

      An untoward medical occurrence, unintended disease or injury, or unanticipated complication

    13. Infection Rate [From date of randomization until hospital discharge, assessed up to 30 days]

      Healthcare associated infection

    14. Incidence of Shivering [Up to 14 days]

      Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale

    Other Outcome Measures

    1. Length of Stay [From date of randomization until hospital discharge, assessed up to 90 days]

      ICU and overall hospital length of stay

    2. Mortality [7-day (or hospital discharge); 3-, 6-, and 12-months]

      Mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage

    2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)

    3. Meets disease-specific criteria

    Exclusion Criteria:

    1. Fever (≥38°C) prior to study enrollment

    2. Pre-existing neurological, psychiatric, or other condition that would confound neurological assessment or would make it difficult to accurately assess neurologic and/or functional outcome

    3. Has a pre-morbid condition with poor likelihood of survival to 6 months

    4. Has a pre-morbid mRS ≥3

    5. Diagnosed with brain death

    6. Is undergoing therapeutic hypothermia therapy

    7. Has sustained neurological injury felt to be catastrophic with little chance of recovery

    8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e., skin that has signs of ulceration, burns, hives, or rash)

    9. Has poor skin integrity or poor tissue perfusion

    10. Participation in a concurrent investigational / interventional study (medical device or drug)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California Los Angeles California United States 90033
    2 Stanford University Hospital Palo Alto California United States 94304
    3 University of Colorado Hospital Aurora Colorado United States 80045
    4 Swedish Medical Center Englewood Colorado United States 80113
    5 Yale New Haven Hospital New Haven Connecticut United States 06520
    6 University of Florida Gainesville Florida United States 32610
    7 Rush University Chicago Illinois United States 60612
    8 Norton Neuroscience Institute Louisville Kentucky United States 40241
    9 Tulane Medical Center New Orleans Louisiana United States 70112
    10 University of Maryland Medical Center Baltimore Maryland United States 21201
    11 Boston University Medical Center Boston Massachusetts United States 02118
    12 University of Massachusetts Worcester Worcester Massachusetts United States 01655
    13 Henry Ford Hospital Detroit Michigan United States 48202
    14 Spectrum Health Hospitals Grand Rapids Michigan United States 49506
    15 Washington University Saint Louis Missouri United States 63110
    16 The University of New Mexico Health Science Center Albuquerque New Mexico United States 87131
    17 Mount Sinai Hospital New York New York United States 10029
    18 Columbia University, New York - Presbyterian Hospital New York New York United States 10032
    19 Duke University Medical Center Durham North Carolina United States 27710
    20 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    21 Ohio State University Wexner Medical Center Columbus Ohio United States 43210
    22 Riverside Methodist Hospital Columbus Ohio United States 43214
    23 Providence St Vincent Medical Center Portland Oregon United States 97225
    24 Hershey Medical Center Hershey Pennsylvania United States 17033
    25 Rhode Island Hospital Providence Rhode Island United States 02903
    26 Erlanger Health System Baroness Hospital Chattanooga Tennessee United States 37403
    27 The University of Texas Health Science Center at Houston Houston Texas United States 77030
    28 Harborview Medical Center Seattle Washington United States 98104
    29 Royal North Shore Hospital Sydney New South Wales Australia 2065
    30 Royal Adelaide Hospital Adelaide South Australia Australia
    31 Medizinische Universität Innsbruck Innsbruck Austria A-6020
    32 Charité - Universitätsmedizin Berlin Berlin Germany D-10117
    33 Technische Universitat Dresden Dresden Germany 01062
    34 Universitätsklinikum Jena Jena Germany 07747
    35 LMU München, Klinikum Großhadern Munich Germany 81377
    36 Keimyung University Dongsan Hospital Daegu Korea, Republic of
    37 Asan Medical Center Seoul Korea, Republic of
    38 Seoul National University Bundang Hospital Seoul Korea, Republic of
    39 Seoul National University Hospital Seoul Korea, Republic of
    40 Universitätsspital Zürich Zürich Switzerland 8091

    Sponsors and Collaborators

    • C. R. Bard
    • Yale University
    • Boston University

    Investigators

    • Principal Investigator: David M. Greer, MD, MA, Boston University
    • Principal Investigator: Kevin N. Sheth, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    C. R. Bard
    ClinicalTrials.gov Identifier:
    NCT02996266
    Other Study ID Numbers:
    • BMD-1111
    First Posted:
    Dec 19, 2016
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by C. R. Bard
    Targeted Temperature Management
    Additional relevant MeSH terms:
    Ischemic Stroke
    Subarachnoid Hemorrhage
    Cerebral Hemorrhage
    Hemorrhage
    Fever

    Study Results

    No Results Posted as of Jun 21, 2022