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

Not Applicable

Completed

• Conditions: Severe Traumatic Brain Injury; Subarachnoid Hemorrhage
• Interventions: Other: Stepwise normothermia protocol; Drug: Ibuprofen; Drug: Acetominophen

• Registration Number: NCT00890604
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-29
• Study First Posted: 2009-04-30
• Study Start: 2009-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2019-06
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard interventions for temperature control used in protocolized, stepwise fashion	Ibuprofen	Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)
Standard interventions for temperature control used in protocolized, stepwise fashion	Stepwise normothermia protocol	Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)
Standard interventions for temperature control used in protocolized, stepwise fashion	Acetominophen	Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)

Primary Outcome Measures

Name	Time	Method
Glasgow Coma Score	24 hour

Secondary Outcome Measures

Name	Time	Method
temperature	hourly
length of stay (intensive care, hospital)	discharge

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States