Impact of Fever Prevention in Brain Injured Patients

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 12, 2022

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.

Interventions

  • Device: Targeted Temperature Management
    • Prophylactic normothermia
  • Other: Standard Care
    • No intervention to control temperature unless fever occurs

Arms, Groups and Cohorts

  • Experimental: Fever Prevention
    • Fever will be prevented using a surface targeted temperature management system
  • Active Comparator: Standard Care
    • Standard care in which fever may spontaneously develop

Clinical Trial Outcome Measures

Primary Measures

  • Fever Burden
    • Time Frame: Up to 14 days
    • Daily average fever burden (°C-hour)

Secondary Measures

  • Primary Neurologic Outcome: Modified Rankin Scale Short-Term
    • Time Frame: 3-months post injury
    • Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
  • Other Neurologic Outcomes: NIH Stroke Scale Short-Term
    • Time Frame: 3-months post injury
    • NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
  • Other Neurologic Outcomes: Barthel Index Short-Term
    • Time Frame: 3-months post injury
    • Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
  • Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term
    • Time Frame: 3-months post injury
    • Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
  • Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term
    • Time Frame: 3-months post injury
    • Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
  • Primary Neurologic Outcome: Modified Rankin Scale Mid-Term
    • Time Frame: 6-months post injury
    • Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
  • Other Neurologic Outcomes: NIH Stroke Scale Mid-Term
    • Time Frame: 6-months post injury
    • NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
  • Other Neurologic Outcomes: Barthel Index Mid-Term
    • Time Frame: 6-months post injury
    • Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
  • Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term
    • Time Frame: 6-months post injury
    • Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
  • Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term
    • Time Frame: 6-months post injury
    • Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
  • Primary Neurologic Outcome: Modified Rankin Scale Long-Term
    • Time Frame: 12-months post injury
    • Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
  • 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
  • Major Adverse Events
    • Time Frame: From date of randomization until end of study, assessed up to 12 months
    • MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death
  • Number of Participants With Infection
    • Time Frame: From date of randomization until hospital discharge, assessed up to 30 days
    • Healthcare associated infection
  • Number of Subjects With Shivering
    • Time Frame: Up to 14 days
    • Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale (BSAS). BSAS scores range from 0-3 with 0 indicating no shivering noted and 3 indicating severe shivering involving gross movements of the trunk and upper and lower extremities.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • C. R. Bard
  • Collaborator
    • Yale University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David M. Greer, MD, MA, Principal Investigator, Boston University
    • Kevin N. Sheth, MD, Principal Investigator, Yale University

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