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:
Collaborator:
Gaymar Industries, Inc.
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00890604
First received: April 28, 2009
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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 Intervention
Subarachnoid Hemorrhage
Severe Traumatic Brain Injury
Drug: Acetaminophen
Other: Usual Care
Drug: Ibuprofen
Other: Physical Cooling Measures
Device: Cooling Blanket
Device: Hydrogel Cooling Pads

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Glasgow Coma Score [ Time Frame: 24 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • temperature [ Time Frame: hourly ] [ Designated as safety issue: No ]
  • length of stay (intensive care, hospital) [ Time Frame: discharge ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890604

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States
Sponsors and Collaborators
University of Washington
Gaymar Industries, Inc.
Investigators
Principal Investigator: Brenda Everett Harborview Injury Prevention and Research Center
Principal Investigator: Robin Hilier Harborview Injury Prevention and Research Center
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00890604     History of Changes
Other Study ID Numbers: 34140-B
Study First Received: April 28, 2009
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
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
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014