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Impact of Fever Prevention in Brain Injured Patients (INTREPID)

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ClinicalTrials.gov Identifier: NCT02996266
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : November 12, 2020
Sponsor:
Collaborators:
Yale University
Boston University
Information provided by (Responsible Party):
C. R. Bard

Study Description
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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
Fever Ischemic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage Device: Targeted Temperature Management Other: Standard Care Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Fever Prevention in Brain Injured Patients
Study Start Date : January 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fever Prevention
Fever will be prevented using a surface targeted temperature management system
 Device: Targeted Temperature Management
Prophylactic normothermia
Other Name: 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
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Primary Outcome Measures :
  1. Fever Burden [ Time Frame: Up to 14 days ]
    Daily average fever burden (°C-hour)


Secondary Outcome Measures :
  1. Primary Neurologic Outcome: Short-Term [ Time Frame: 3-months post injury ]
    Modified Rankin Scale

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

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

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

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

  6. Primary Neurologic Outcome: Mid-Term [ Time Frame: 6-months post injury ]
    Modified Rankin Scale

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

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

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

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

  11. Primary Neurologic Outcome: Long-Term [ Time Frame: 12-months post injury ]
    Modified Rankin Scale

  12. Adverse Events [ Time Frame: 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 [ Time Frame: From date of randomization until hospital discharge, assessed up to 30 days ]
    Healthcare associated infection

  14. Incidence of Shivering [ Time Frame: Up to 14 days ]
    Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale


Other Outcome Measures:
  1. Length of Stay [ Time Frame: From date of randomization until hospital discharge, assessed up to 90 days ]
    ICU and overall hospital length of stay

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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT02996266


Contacts
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Contact: Peter Fayek (847) 362-8796 peter.fayek@bd.com

Locations
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Sponsors and Collaborators
C. R. Bard
Yale University
Boston University
Investigators
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Principal Investigator: David M. Greer, MD, MA Boston University
Principal Investigator: Kevin N. Sheth, MD Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02996266    
Other Study ID Numbers: BMD-1111
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by C. R. Bard:
Targeted Temperature Management
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Cerebral Hemorrhage
Hemorrhage
Fever
Pathologic Processes
Body Temperature Changes
Intracranial Hemorrhages
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases