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

Sponsor

University of Washington (Other)

Overall Status

Terminated

CT.gov ID

NCT00890604

Collaborator

Gaymar Industries, Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

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 :

Jul 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Gaymar Rap'r Round Device: Hydrogel Cooling Pads Application to torso and extremities Other Names: Arctic Sun

Arm

Intervention/Treatment

Other: 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 Names:

Gaymar Rap'r Round

Device: Hydrogel Cooling Pads

Application to torso and extremities

Other Names:

Arctic Sun

Outcome Measures

Primary Outcome Measures

Glasgow Coma Score [24 hour]

Secondary Outcome Measures

temperature [hourly]
length of stay (intensive care, hospital) [discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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