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Temperature Control in Central Fever in the Neuro-ICU

This study has been completed.
Sponsor:
Collaborator:
Gaymar Industries, Inc.
Information provided by (Responsible Party):
Andrew Naidech, Northwestern University
ClinicalTrials.gov Identifier:
NCT00751634
First received: September 10, 2008
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Temperature Control in Central Fever in the Neuro-ICU

Resource links provided by NLM:

MedlinePlus related topics: Fever
U.S. FDA Resources

Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period

  • Number of Participants With Arrhythmia [ Time Frame: Six hours ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Andrew Naidech, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00751634     History of Changes
Other Study ID Numbers: 1507-009
Study First Received: September 10, 2008
Results First Received: January 9, 2012
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
subarachnoid hemorrhage
intracerebral hemorrhage
fever

Additional relevant MeSH terms:
Fever
Hemorrhage
Cerebral Hemorrhage
Intracranial Hemorrhages
Body Temperature Changes
Signs and Symptoms
Pathologic Processes
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013