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Completed

NCT Number: NCT00751634

Temperature Control in Central Fever in the Neuro-ICU

There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.

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Key information

Conditions

Fever Body Temperature Changes Brain Diseases Brain Hemorrhage Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Two or more days with core temperature ≥ 100.4F
  • Approval of the patient's primary attending physician
  • Need for core temperature measurement independent of the study.
  • Admission to the Neuro-ICU [intensive care unit] for an underlying condition

Exclusion criteria

  • Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection.
  • Expected death from any cause
  • Known sensitivity to the device
  • History of pre-admission hypothalamic dysfunction or known temperature dysregulation
  • Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely
  • Hemodynamic instability

Treatment and study plan

Gaymar Rapr-Round (external cooling blanket)

Device

Application of the device per its approved labeling

Primary outcomes

  1. Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care

    Time frame: baseline, one, two and six hours after application.

    Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.

Secondary outcomes

  1. Time From Start of Cooling Device to Core Temperature < 100.4F

    Time frame: Six hours

    For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F

  2. Number of Participants With Severe Shivering

    Time frame: six hours

    Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall

    • Mild: shivering localized to the neck and/or thorax only
    • Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)
    • Severe: shivering involves gross movements of the trunk and upper and lower extremities

  3. Number of Participants With Hypotension

    Time frame: six hours

    New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period

  4. Number of Participants With Arrhythmia

    Time frame: Six hours

    New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Gaymar Industries, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 12, 2008
Registry last updated
May 6, 2013

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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