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

NCT ID: NCT00890604

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-07-31

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.

Conditions

Subarachnoid Hemorrhage; Severe Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard interventions for temperature control used in protocolized, stepwise fashion

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

Group Type: OTHER

Stepwise normothermia protocol

Intervention Type: OTHER

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.

Ibuprofen

Intervention Type: DRUG

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

Acetominophen

Intervention Type: DRUG

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

Standard fever management/prevention interventions used in ad hoc fashion

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Ibuprofen

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaymar Industries, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Hilaire Thompson

Professor: School of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brenda Everett

Role: PRINCIPAL_INVESTIGATOR

Harborview Injury Prevention and Research Center

Robin Hilier

Role: PRINCIPAL_INVESTIGATOR

Harborview Injury Prevention and Research Center

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

34140

Identifier Type: -

Identifier Source: org_study_id