Clinical trial NCT00890604: Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Official title: Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Severe Traumatic Brain Injury
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Gaymar Industries, Inc.
First posted: 2009-04-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Glasgow Coma Score
timeFrame: 24 hour
Secondary outcomes:
measure: temperature
timeFrame: hourly
measure: length of stay (intensive care, hospital)
timeFrame: discharge
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Harborview Injury Prevention and Research Center
name: Brenda Everett
role: PRINCIPAL_INVESTIGATOR
affiliation: Harborview Injury Prevention and Research Center
name: Robin Hilier
role: PRINCIPAL_INVESTIGATOR
References: