Trial | NCT00890604  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    10
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.
Study Started
Jul 31
2009
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
May 08
2017

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 names: Gaymar Rap'r Round

Device Hydrogel Cooling Pads

Application to torso and extremities

  • Other names: Arctic Sun

1 Other

Usual Care

2 Experimental

Normothermia Protocol

Criteria 

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
No Results Posted