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

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

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage; Severe Traumatic Brain Injury
• Intervention / Treatment: Other: Stepwise normothermia protocol; Drug: Ibuprofen; Drug: Acetominophen

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard interventions for temperature control used in protocolized, stepwise fashion; Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)	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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glasgow Coma Score	24 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
temperature	hourly
length of stay (intensive care, hospital)	discharge

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Gaymar Industries, Inc.
• Investigators: Principal Investigator: Brenda Everett, Harborview Injury Prevention and Research Center; Principal Investigator: Robin Hilier, Harborview Injury Prevention and Research Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: April 29, 2009
• First Posted (Estimated): April 30, 2009

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 34140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No