Impact of Fever Prevention in Brain Injured Patients
Status: | Recruiting |
---|---|
Conditions: | Infectious Disease, Neurology, Neurology |
Therapuetic Areas: | Immunology / Infectious Diseases, Neurology |
Healthy: | No |
Age Range: | 21 - 85 |
Updated: | 4/3/2019 |
Start Date: | January 2017 |
End Date: | December 2020 |
Contact: | Peter Fayek |
Email: | peter.fayek@bd.com |
Phone: | (847) 362-8796 |
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.
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.
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.
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)
We found this trial at
26
sites
12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Phone: 720-848-5490
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-6170
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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University of Southern California The University of Southern California is one of the world’s leading...
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593 Eddy Street
Providence, Rhode Island 02903
Providence, Rhode Island 02903
401-444-4000
Phone: 401-444-8362
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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22 S Greene St
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-328-7939
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Phone: 617-638-5309
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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975 East 3rd Street
Chattanooga, Tennessee 37403
Chattanooga, Tennessee 37403
Phone: 423-802-2075
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3535 Olentangy River Rd
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Phone: 614-905-2698
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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501 E. Hampden Ave.
Englewood, Colorado 80113
Englewood, Colorado 80113
303-788-5000
Phone: 303-809-3374
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20 York St, N20 York St,
New Haven, Connecticut 06520
New Haven, Connecticut 06520
(203) 688-4242
Phone: 203-785-6288
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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9205 SW Barnes Rd
Portland, Oregon 97225
Portland, Oregon 97225
(503) 216-1234
Phone: 503-913-0187
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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