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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00890604
Other study ID # 34140
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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