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.

Study Overview

• Status: Completed
• Conditions: Fever; Brain Hemorrhage
• Intervention / Treatment: Device: Gaymar Rapr-Round (external cooling blanket)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care	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.	baseline, one, two and six hours after application.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time From Start of Cooling Device to Core Temperature < 100.4F	For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F	Six hours
Number of Participants With Severe Shivering	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	six hours
Number of Participants With Hypotension	New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period	six hours
Number of Participants With Arrhythmia	New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm	Six hours

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Gaymar Industries, Inc.
• Investigators: Principal Investigator: Andrew M Naidech, MD MSPH, Northwestern University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 10, 2008
• First Submitted That Met QC Criteria: September 10, 2008
• First Posted (Estimate): September 12, 2008

Study Record Updates

• Last Update Posted (Estimate): May 6, 2013
• Last Update Submitted That Met QC Criteria: April 30, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: fever; intracerebral hemorrhage; subarachnoid hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Temperature Changes; Hemorrhage; Fever; Intracranial Hemorrhages
• Other Study ID Numbers: 1507-009