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

University of Washington

Status: Completed

Conditions: Subarachnoid Hemorrhage; Severe Traumatic Brain Injury

Treatments: Drug: Acetominophen; Other: Stepwise normothermia protocol; Drug: Ibuprofen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00890604

34140

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Standard interventions for temperature control used in protocolized, stepwise fashion

Other group

Description:

Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)

Treatment:

Drug: Acetominophen

Other: Stepwise normothermia protocol

Drug: Ibuprofen

Standard fever management/prevention interventions used in ad hoc fashion

No Intervention group

Description:

standard interventions for fever prevention used in ad hoc fashion based on nurse decision making