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Temperature Control in Central Fever in the Neuro-ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751634
Recruitment Status : Completed
First Posted : September 12, 2008
Results First Posted : April 9, 2012
Last Update Posted : May 6, 2013
Gaymar Industries, Inc.
Information provided by (Responsible Party):
Andrew Naidech, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fever Brain Hemorrhage Device: Gaymar Rapr-Round (external cooling blanket) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Temperature Control in Central Fever in the Neuro-ICU
Study Start Date : January 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: A
Application of the Gaymar Rapr-Round device per approved use
Device: Gaymar Rapr-Round (external cooling blanket)
Application of the device per its approved labeling

Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. Mild: shivering localized to the neck and/or thorax only
    2. Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)
    3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751634

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Gaymar Industries, Inc.
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Principal Investigator: Andrew M Naidech, MD MSPH Northwestern University
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Responsible Party: Andrew Naidech, Associate Professor, Northwestern University Identifier: NCT00751634    
Other Study ID Numbers: 1507-009
First Posted: September 12, 2008    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: May 6, 2013
Last Verified: April 2013
Keywords provided by Andrew Naidech, Northwestern University:
subarachnoid hemorrhage
intracerebral hemorrhage
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases