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OpenTrials
Completed

NCT Number: NCT00890604

Outcomes Associated With Application of a 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Glasgow Coma Score

    Time frame: 24 hour

Secondary outcomes

  1. temperature

    Time frame: hourly

  2. length of stay (intensive care, hospital)

    Time frame: discharge

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Gaymar Industries, Inc.

Registry information

Official study title

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

Acronym: SNIF

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2009
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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