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

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. Identifier: NCT00890604
Recruitment Status : Terminated (Practice change created contamination of usual care arm)
First Posted : April 30, 2009
Last Update Posted : May 8, 2017
Gaymar Industries, Inc.
Information provided by (Responsible Party):
Brenda Everett, University of Washington

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Severe Traumatic Brain Injury Drug: Acetaminophen Other: Usual Care Drug: Ibuprofen Other: Physical Cooling Measures Device: Cooling Blanket Device: Hydrogel Cooling Pads Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Usual Care
Other: Usual Care
Care per attending physician discretion for fever management

Experimental: 2
Normothermia Protocol
Drug: Acetaminophen
APAP 650mg q4h prn; RTC dosing

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

Primary Outcome Measures :
  1. Glasgow Coma Score [ Time Frame: 24 hour ]

Secondary Outcome Measures :
  1. temperature [ Time Frame: hourly ]
  2. length of stay (intensive care, hospital) [ Time Frame: discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890604

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United States, Washington
Harborview Medical Center
Seattle, Washington, United States
Sponsors and Collaborators
University of Washington
Gaymar Industries, Inc.
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Principal Investigator: Brenda Everett Harborview Injury Prevention and Research Center
Principal Investigator: Robin Hilier Harborview Injury Prevention and Research Center
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Responsible Party: Brenda Everett, RN, Interventional Radiology, University of Washington Identifier: NCT00890604    
Other Study ID Numbers: 34140-B
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action