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Temperature Control in Central Fever in the Neuro-ICU

Primary Purpose

Fever, Brain Hemorrhage

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gaymar Rapr-Round (external cooling blanket)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fever focused on measuring subarachnoid hemorrhage, intracerebral hemorrhage, fever

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Application of the Gaymar Rapr-Round device per approved use

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Number of Participants With Hypotension
New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period
Number of Participants With Arrhythmia
New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm

Full Information

First Posted
September 10, 2008
Last Updated
April 30, 2013
Sponsor
Northwestern University
Collaborators
Gaymar Industries, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00751634
Brief Title
Temperature Control in Central Fever in the Neuro-ICU
Official Title
Temperature Control in Central Fever in the Neuro-ICU
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Gaymar Industries, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Brain Hemorrhage
Keywords
subarachnoid hemorrhage, intracerebral hemorrhage, fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Application of the Gaymar Rapr-Round device per approved use
Intervention Type
Device
Intervention Name(s)
Gaymar Rapr-Round (external cooling blanket)
Intervention Description
Application of the device per its approved labeling
Primary Outcome Measure Information:
Title
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care
Description
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.
Time Frame
baseline, one, two and six hours after application.
Secondary Outcome Measure Information:
Title
Time From Start of Cooling Device to Core Temperature < 100.4F
Description
For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F
Time Frame
Six hours
Title
Number of Participants With Severe Shivering
Description
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
Time Frame
six hours
Title
Number of Participants With Hypotension
Description
New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period
Time Frame
six hours
Title
Number of Participants With Arrhythmia
Description
New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm
Time Frame
Six hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew M Naidech, MD MSPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Temperature Control in Central Fever in the Neuro-ICU

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