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

Subarachnoid Hemorrhage Clinical Trial

— SNIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890604
• Other study ID #: 34140
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Severe Traumatic Brain Injury
• Subarachnoid Hemorrhage

Intervention

Other:
• Stepwise normothermia protocol
Use of standard care interventions in a protocolized/step-wise fashion instead of ad hoc based on nurse decision making which may include antipyretics, physical cooling measures.

Drug:
• Ibuprofen
It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.
• Acetominophen
It is not the intent of the study to evaluate this drug but may be provided in conjunction with the Stepwise normothermia protocol.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Gaymar Industries, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Coma Score		24 hour
Secondary	temperature		hourly
Secondary	length of stay (intensive care, hospital)		discharge