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NCT00890604 · ClinicalTrials.gov registry record · NA
Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT00890604 is a NA study that has completed, run by University of Washington. The registered enrollment target is 10 participants.
The verdict
NCT00890604, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ibuprofen
- DRUG Acetominophen
- OTHER Stepwise normothermia protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00890604
The ClinicalTrials.gov registry entry for NCT00890604 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ibuprofen is the first listed.
NCT00890604 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00890604 about?
NCT00890604 is a clinical study titled "Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever". 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 pediatr...
What is the current status of trial NCT00890604?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2009-07. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00890604?
The interventions under investigation include: Ibuprofen (DRUG), Acetominophen (DRUG), Stepwise normothermia protocol (OTHER).
Who is sponsoring clinical trial NCT00890604?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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