Temperature Control in Central Fever in the Neuro-ICU

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00751634
• Collaborator: Gaymar Industries, Inc. (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.8

Study Details

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.

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

Study Design

• Study Type: Interventional
• 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: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care [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 [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 [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 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

3. Number of Participants With Hypotension [six hours]

   New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period

4. Number of Participants With Arrhythmia [Six hours]

   New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrew Naidech, Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT00751634
• Other Study ID Numbers: 1507-009
• First Posted: Sep 12, 2008
• Last Update Posted: May 6, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Andrew Naidech, Associate Professor, Northwestern University: subarachnoid hemorrhage; intracerebral hemorrhage; fever
• Additional relevant MeSH terms: Intracranial Hemorrhages; Hemorrhage; Fever

Study Results

Participant Flow

Arm/Group Title	Treatment Group
Arm/Group Description	Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment Group
Arm/Group Description	Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.3 (15.4)
Sex: Female, Male (Count of Participants)
Female	7 35%
Male	13 65%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group at 0, 1, 2, 6 Hours
Arm/Group Description	Application of the Gaymar Rapr-Round device per approved use
Measure Participants	20
0 hours	100.8 (0.4)
1 hour	100.3 (0.9)
2 hours	99.9 (1.1)
6 hours	99.5 (0.7)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Measure Participants	20
Mean (Standard Deviation) [hours]	2.1 (1.6)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants were analyzed for the outcome of BSAS=3

Arm/Group Title	Treatment Group
Arm/Group Description	Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Measure Participants	20
Number [participants]	4 20%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Measure Participants	20
Number [participants]	0 0%

5. Secondary Outcome

Title	Number of Participants With Arrhythmia
Description	New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm
Time Frame	Six hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
Measure Participants	20
Number [participants]	0 0%

Adverse Events

Arm/Group Title	Treatment Group
Arm/Group Description	Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting)
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	4/20 (20%)
Nervous system disorders
Shivering	4/20 (20%)	4
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.