Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever (SNIF)
Primary Purpose
Subarachnoid Hemorrhage, Severe Traumatic Brain Injury
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Usual Care
Ibuprofen
Physical Cooling Measures
Cooling Blanket
Hydrogel Cooling Pads
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Temperature > 38.3 Celsius
Meet brain injury criteria:
- Traumatic brain injury with Glasgow Coma Scale score of 8 or less
- Subarachnoid hemorrhage without vasospasm- Hunt and Hess grade III and below
- Subarachnoid hemorrhage with vasospasm
- First febrile episode
- English speaking
Exclusion Criteria:
- Skin breakdown
- Bleeding disorders
- Increased risk for clotting
- Ongoing seizure activity
- Allergy to medications used in the study
- Prisoners
- Pregnancy
Sites / Locations
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
1
2
Arm Description
Usual Care
Normothermia Protocol
Outcomes
Primary Outcome Measures
Glasgow Coma Score
Secondary Outcome Measures
temperature
length of stay (intensive care, hospital)
Full Information
NCT ID
NCT00890604
First Posted
April 28, 2009
Last Updated
May 3, 2017
Sponsor
University of Washington
Collaborators
Gaymar Industries, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00890604
Brief Title
Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Acronym
SNIF
Official Title
Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Practice change created contamination of usual care arm
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Gaymar Industries, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
When fever is present in patients with stroke, traumatic brain injury (TBI), or brain hemorrhage, it has been associated with worse outcomes including larger areas of tissue death, increased length of stay, worse degree of coma, lower ability to function, and higher mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal body temperature should be a standard of care. However, no further standards or options are presented to specifically guide practice. The current ischemic stroke guidelines state that fever should be treated with fever-reducing agents and offer "cooling devices" as an option but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of their stay. With elevated temperatures the body consumes more oxygen than if the temperature was normal, causing less oxygen to be available to the brain. This may lead to injury of the brain cells and a diminished capacity for healing. Thus, temperature management in neurologically vulnerable patients is both a prevalent and problematic challenge. Based on this information the goal of the present proposal is to evaluate if 1) A standardized, step-wise approach to temperature management using a Normothermia Protocol is successful in achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If maintenance of normal temperature will be associated with fewer episodes of diminished responsiveness in their neurological exams as evidenced by a measure of depth of coma, as measured by the Glasgow Coma Score (GCS) compared to a control group treated according to usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Severe Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Usual Care
Arm Title
2
Arm Type
Experimental
Arm Description
Normothermia Protocol
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
APAP 650mg q4h prn; RTC dosing
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Care per attending physician discretion for fever management
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Ibuprofen 600mg q6h
Intervention Type
Other
Intervention Name(s)
Physical Cooling Measures
Intervention Description
Fan, Ice Packs
Intervention Type
Device
Intervention Name(s)
Cooling Blanket
Other Intervention Name(s)
Gaymar Rap'r Round
Intervention Description
Water Circulating Cooling Blanket
Intervention Type
Device
Intervention Name(s)
Hydrogel Cooling Pads
Other Intervention Name(s)
Arctic Sun
Intervention Description
Application to torso and extremities
Primary Outcome Measure Information:
Title
Glasgow Coma Score
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
temperature
Time Frame
hourly
Title
length of stay (intensive care, hospital)
Time Frame
discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Temperature > 38.3 Celsius
Meet brain injury criteria:
Traumatic brain injury with Glasgow Coma Scale score of 8 or less
Subarachnoid hemorrhage without vasospasm- Hunt and Hess grade III and below
Subarachnoid hemorrhage with vasospasm
First febrile episode
English speaking
Exclusion Criteria:
Skin breakdown
Bleeding disorders
Increased risk for clotting
Ongoing seizure activity
Allergy to medications used in the study
Prisoners
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Everett
Organizational Affiliation
Harborview Injury Prevention and Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Hilier
Organizational Affiliation
Harborview Injury Prevention and Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
We'll reach out to this number within 24 hrs