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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
686
Prophylactic normothermia
No intervention to control temperature unless fever occurs
Fever Burden
Daily average fever burden (°C-hour)
Time frame: Up to 14 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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University of Southern California
Los Angeles, California, United States
Stanford University Hospital
Palo Alto, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Rush University
Chicago, Illinois, United States
Norton Neuroscience Institute
Louisville, Kentucky, United States
Tulane Medical Center
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
...and 30 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-months post injury
Adverse Events
An untoward medical occurrence, unintended disease or injury, or unanticipated complication
Time frame: 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
Time frame: From date of randomization until end of study, assessed up to 12 months
Number of Participants With Infection
Healthcare associated infection
Time frame: 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.
Time frame: Up to 14 days