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Temperature Control in Central Fever in the Neuro-ICU

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00751634
First Posted: September 12, 2008
Last Update Posted: May 6, 2013
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.
Collaborator:
Gaymar Industries, Inc.
Information provided by (Responsible Party):
Andrew Naidech, Northwestern University
  Purpose
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 Intervention Phase
Fever Brain Hemorrhage Device: Gaymar Rapr-Round (external cooling blanket) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Temperature Control in Central Fever in the Neuro-ICU

Resource links provided by NLM:


Further study details as provided by Andrew Naidech, Northwestern University:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • Number of Participants With Hypotension [ Time Frame: six hours ]
    New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period

  • Number of Participants With Arrhythmia [ Time Frame: Six hours ]
    New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm


Enrollment: 20
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00751634


Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Gaymar Industries, Inc.
Investigators
Principal Investigator: Andrew M Naidech, MD MSPH Northwestern University
  More Information

Responsible Party: Andrew Naidech, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00751634     History of Changes
Other Study ID Numbers: 1507-009
First Submitted: September 10, 2008
First Posted: September 12, 2008
Results First Submitted: January 9, 2012
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
fever

Additional relevant MeSH terms:
Hemorrhage
Fever
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