Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever
|
Status:
This study is currently recruiting participants.
Purpose:
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:
Aspirin
Antiplatelet agent; inhibits thromboxane A2; antipyretic
|
Cooling blanket
lower body temperature
|
Hydrogel Cooling Pads
lower body temperature with cold applications to extremities
|
Ibuprofen
a non-steroidal anti-inflammatory drug (NSAID). It is used for relief of symptoms of arthritis, primary dysmenorrhea, fever, and as an analgesic, especially where there is an inflammatory component. Ibuprofen is known to have an antiplatelet effect, though it is relatively mild and short-lived when compared with that of aspirin or other better-known antiplatelet drugs.
|
Physical Cooling Measures
fan, ice packs
|
Standard Medical Care
per the National Guidelines for Stroke.
|
Year Started:
2009
Design:
Interventional, Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study.
Inclusion Criteria
Temperature > 38.3 Celsius; 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; first febrile episode; English speaking.
Exclusion Criteria
Skin breakdown; bleeding disorders; increased risk for clotting; ongoing seizure activity; allergy to medications used in the study; prisoners; pregnancy.
Patient Involvement:
Patient will be randomized to one of two arms: Usual standard of care per their physician or the experimental arm receiving A standardized, step-wise approach to temperature management using a Normothermia Protocol.
Primary Outcome:
Glasgow Coma Score
Secondary Outcome:
temperature; length of stay
|
Source of Information:
ClinicalTrials.gov
|
Web Links and Publications:
|
|
This information last updated on: 5/25/2010
Reviewed on: 05/25/2010.
|
Trials
Directories