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

NCT00890604 | Completed

• 1 other identifier: 34140
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Glasgow Coma Score

  24 hour

Secondary Outcomes (2)

• temperature

  hourly

• length of stay (intensive care, hospital)

  discharge

Study Arms (2)

Standard interventions for temperature control used in protocolized, stepwise fashion

OTHER

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

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

Standard fever management/prevention interventions used in ad hoc fashion

NO INTERVENTION

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

Interventions

Stepwise normothermia protocol 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.

Standard interventions for temperature control used in protocolized, stepwise fashion

Ibuprofen 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 interventions for temperature control used in protocolized, stepwise fashion

Acetominophen 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 interventions for temperature control used in protocolized, stepwise fashion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Skin breakdown
• Bleeding disorders
• Increased risk for clotting
• Ongoing seizure activity
• Allergy to medications used in the study
• Prisoners
• Pregnancy

Sponsors & Collaborators

• University of Washington: lead
• Gaymar Industries, Inc.: collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Brain Injuries, Traumatic

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Brenda Everett

  Harborview Injury Prevention and Research Center

  PRINCIPAL INVESTIGATOR

• Robin Hilier

  Harborview Injury Prevention and Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Nursing

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 30, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 30, 2024

Record last verified: 2019-06

Locations

US (1)