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

Study Overview
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Brief Summary
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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.

Official Title
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Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever

Conditions
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Subarachnoid Hemorrhage, Severe Traumatic Brain Injury

Intervention / Treatment
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* Drug: Acetaminophen
* Other: Usual Care
* Drug: Ibuprofen
* Other: Physical Cooling Measures
* Device: Cooling Blanket
* Device: Hydrogel Cooling Pads


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Usual Care | Other: Usual Care<br>* Care per attending physician discretion for fever management<br>|
| Experimental: 2<br>Normothermia Protocol | Drug: Acetaminophen<br>* APAP 650mg q4h prn; RTC dosing<br>Drug: Ibuprofen<br>* Ibuprofen 600mg q6h<br>Other: Physical Cooling Measures<br>* Fan, Ice Packs<br>Device: Cooling Blanket<br>* Water Circulating Cooling Blanket<br>* Other names: Gaymar Rap'r Round;Device: Hydrogel Cooling Pads<br>* Application to torso and extremities<br>* Other names: Arctic Sun;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma Score |  | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| temperature |  | hourly | 
| length of stay (intensive care, hospital) |  | discharge |