We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever (SNIF)

This study has been terminated.
(Practice change created contamination of usual care arm)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00890604
First Posted: April 30, 2009
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gaymar Industries, Inc.
Information provided by (Responsible Party):
Brenda Everett, University of Washington
April 28, 2009
April 30, 2009
May 8, 2017
July 2009
July 2010   (Final data collection date for primary outcome measure)
Glasgow Coma Score [ Time Frame: 24 hour ]
Same as current
Complete list of historical versions of study NCT00890604 on ClinicalTrials.gov Archive Site
  • temperature [ Time Frame: hourly ]
  • length of stay (intensive care, hospital) [ Time Frame: discharge ]
Same as current
Not Provided
Not Provided
 
Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Subarachnoid Hemorrhage
  • Severe Traumatic Brain Injury
  • Drug: Acetaminophen
    APAP 650mg q4h prn; RTC dosing
  • Other: Usual Care
    Care per attending physician discretion for fever management
  • Drug: Ibuprofen
    Ibuprofen 600mg q6h
  • Other: Physical Cooling Measures
    Fan, Ice Packs
  • Device: Cooling Blanket
    Water Circulating Cooling Blanket
    Other Name: Gaymar Rap'r Round
  • Device: Hydrogel Cooling Pads
    Application to torso and extremities
    Other Name: Arctic Sun
  • 1
    Usual Care
    Intervention: Other: Usual Care
  • Experimental: 2
    Normothermia Protocol
    Interventions:
    • Drug: Acetaminophen
    • Drug: Ibuprofen
    • Other: Physical Cooling Measures
    • Device: Cooling Blanket
    • Device: Hydrogel Cooling Pads
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Temperature > 38.3 Celsius
  2. 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
  3. First febrile episode
  4. English speaking

Exclusion Criteria:

  1. Skin breakdown
  2. Bleeding disorders
  3. Increased risk for clotting
  4. Ongoing seizure activity
  5. Allergy to medications used in the study
  6. Prisoners
  7. Pregnancy
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00890604
34140-B
No
Not Provided
Not Provided
Brenda Everett, University of Washington
University of Washington
Gaymar Industries, Inc.
Principal Investigator: Brenda Everett Harborview Injury Prevention and Research Center
Principal Investigator: Robin Hilier Harborview Injury Prevention and Research Center
University of Washington
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP