Impact of Fever Prevention in Brain Injured Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Fever Prevention in Brain Injured Patients

Conditions
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Fever, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage

Intervention / Treatment
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* Device: Targeted Temperature Management
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2) Meets disease-specific criteria Exclusion Criteria: Fever (≥38°C) prior to study enrollment 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 Has a pre-morbid condition with poor likelihood of survival to 6 months Has a pre-morbid mRS ≥3 Diagnosed with brain death Is undergoing therapeutic hypothermia therapy Has sustained neurological injury felt to be catastrophic with little chance of recovery 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) Has poor skin integrity or poor tissue perfusion Participation in a concurrent investigational / interventional study (medical device or drug)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fever Prevention<br>Fever will be prevented using a surface targeted temperature management system | Device: Targeted Temperature Management<br>* Prophylactic normothermia<br>* Other names: Arctic Sun 5000 Temperature Management System;|
| Active Comparator: Standard Care<br>Standard care in which fever may spontaneously develop | Other: Standard Care<br>* No intervention to control temperature unless fever occurs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever Burden | Daily average fever burden (°C-hour) | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Neurologic Outcome: Modified Rankin Scale Short-Term | Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death. | 3-months post injury | 
| Other Neurologic Outcomes: NIH Stroke Scale Short-Term | 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. | 3-months post injury | 
| Other Neurologic Outcomes: Barthel Index Short-Term | Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome. | 3-months post injury | 
| Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term | Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome. | 3-months post injury | 
| Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term | Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome. | 3-months post injury | 
| Primary Neurologic Outcome: Modified Rankin Scale Mid-Term | Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death. | 6-months post injury | 
| Other Neurologic Outcomes: NIH Stroke Scale Mid-Term | 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. | 6-months post injury | 
| Other Neurologic Outcomes: Barthel Index Mid-Term | Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome. | 6-months post injury | 
| Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term | Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome. | 6-months post injury | 
| Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term | Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome. | 6-months post injury | 
| Primary Neurologic Outcome: Modified Rankin Scale Long-Term | Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death. | 12-months post injury | 
| Adverse Events | An untoward medical occurrence, unintended disease or injury, or unanticipated complication | From date of randomization until hospital discharge, assessed up to 30 days | 
| Major Adverse Events | MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death | From date of randomization until end of study, assessed up to 12 months | 
| Number of Participants With Infection | Healthcare associated infection | From date of randomization until hospital discharge, assessed up to 30 days | 
| Number of Subjects With Shivering | 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. | Up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Targeted Temperature Management