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

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.

Conditions

• Subarachnoid Hemorrhage
• Severe Traumatic Brain Injury

Interventions

OTHER

Stepwise 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.

DRUG

Ibuprofen

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

DRUG

Acetominophen

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

Sponsors & Collaborators

• Gaymar Industries, Inc.

  collaborator INDUSTRY

• University of Washington

  lead OTHER

Principal Investigators

• Brenda Everett · Harborview Injury Prevention and Research Center

• Robin Hilier · Harborview Injury Prevention and Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2011-07-31

Completion

2011-07-31

Countries

• United States

Study Locations