Impact of Fever Prevention in Brain Injured Patients

Ischemic Stroke Clinical Trial

— INTREPID  

Official title:

Impact of Fever Prevention in Brain Injured Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02996266
• Other study ID #: BMD-1111
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 12, 2022

Study information

• Verified date: August 2023
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 686
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Fever
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemic Stroke
• Subarachnoid Hemorrhage

Intervention

Device:
• Targeted Temperature Management
Prophylactic normothermia

Other:
• Standard Care
No intervention to control temperature unless fever occurs

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal North Shore Hospital	Sydney	New South Wales
Austria	Medizinische Universität Innsbruck	Innsbruck
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Technische Universitat Dresden	Dresden
Germany	Universitätsklinikum Jena	Jena
Germany	LMU München, Klinikum Großhadern	Munich
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Switzerland	Universitätsspital Zürich	Zürich
United States	The University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Boston University Medical Center	Boston	Massachusetts
United States	Erlanger Health System Baroness Hospital	Chattanooga	Tennessee
United States	Rush University	Chicago	Illinois
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Swedish Medical Center	Englewood	Colorado
United States	University of Florida	Gainesville	Florida
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	Norton Neuroscience Institute	Louisville	Kentucky
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Columbia University, New York - Presbyterian Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Stanford University Hospital	Palo Alto	California
United States	Providence St Vincent Medical Center	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Washington University	Saint Louis	Missouri
United States	Harborview Medical Center	Seattle	Washington
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	University of Massachusetts Worcester	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
C. R. Bard	Boston University, Yale University

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Germany,  Korea, Republic of,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital Length of Stay	Overall hospitalization duration	From date of randomization until hospital discharge, assessed up to 90 days
Other	ICU Length of Stay	ICU Duration	From date of randomization until ICU discharge
Other	Mortality	Mortality	7-day (or hospital discharge); 3-, 6-, and 12-months
Primary	Fever Burden	Daily average fever burden (°C-hour)	Up to 14 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Infection	Healthcare associated infection	From date of randomization until hospital discharge, assessed up to 30 days
Secondary	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