Outcomes Associated With Application of a Normothermia Protocol in Patients With Severe Neurological Insult and Fever (SNIF)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Subarachnoid Hemorrhage Severe Traumatic Brain Injury |
Drug: Acetaminophen Other: Usual Care Drug: Ibuprofen Other: Physical Cooling Measures Device: Cooling Blanket Device: Hydrogel Cooling Pads |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever |
- Glasgow Coma Score [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
- temperature [ Time Frame: hourly ] [ Designated as safety issue: No ]
- length of stay (intensive care, hospital) [ Time Frame: discharge ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | July 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Usual Care
|
Other: Usual Care
Care per attending physician discretion for fever management
|
|
Experimental: 2
Normothermia Protocol
|
Drug: Acetaminophen
APAP 650mg q4h prn; RTC dosing
Drug: Ibuprofen
Ibuprofen 600mg q6h
Other: Physical Cooling Measures
Fan, Ice Packs
Device: Cooling Blanket
Water Circulating Cooling Blanket
Other Name: Gaymar Rap'r Round
Device: Hydrogel Cooling Pads
Application to torso and extremities
Other Name: Arctic Sun
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Washington | |
| Harborview Medical Center | |
| Seattle, Washington, United States | |
| Principal Investigator: | Brenda Everett | Harborview Injury Prevention and Research Center |
| Principal Investigator: | Robin Hilier | Harborview Injury Prevention and Research Center |
More Information
No publications provided
| Responsible Party: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00890604 History of Changes |
| Other Study ID Numbers: | 34140-B |
| Study First Received: | April 28, 2009 |
| Last Updated: | June 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Brain Injuries Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Acetaminophen |
Ibuprofen Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013