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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00890604
Acronym
SNIF
Enrollment
10
Registered
2009-04-30
Start date
2009-07-31
Completion date
2011-07-31
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage, Severe Traumatic Brain Injury

Brief 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

OTHERStepwise 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.

DRUGIbuprofen

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

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

Sponsors

Gaymar Industries, Inc.
CollaboratorINDUSTRY
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Glasgow Coma Score24 hour

Secondary

MeasureTime frame
temperaturehourly
length of stay (intensive care, hospital)discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026