Temperature Control in Central Fever in the Neuro-ICU - Full Text View

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 IV

MedlinePlus related topics:

Fever

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Temperature Control in Central Fever in the Neuro-ICU

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Core temperature [ Time Frame: baseline, one, two and six hours after application. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time from start of cooling device to core temperature < 100.4F [ Time Frame: Six hours ] [ Designated as safety issue: No ]
Shivering [ Time Frame: six hours ] [ Designated as safety issue: Yes ]
Hypotension [ Time Frame: six hours ] [ Designated as safety issue: Yes ]
Arrythmia [ Time Frame: Six hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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 for an underlying condition

Exclusion Criteria:

Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS 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

Contacts


Contact: Andrew M Naidech, MD	312-503-3335	a-naidech@northwestern.edu

Locations


United States, Illinois
	Northwestern Memorial Hospital	Not yet recruiting
	Chicago, Illinois, United States, 60611
	Contact: Andrew M Naidech, MD MSPH 312-503-3335 a-naidech@northwestern.edu
	Principal Investigator: Andrew M Naidech, MD MSPH

Sponsors and Collaborators

Northwestern University

Gaymar Industries, Inc.

Investigators


Principal Investigator:	Andrew M Naidech, MD MSPH	Northwestern University

More Information

Responsible Party:	Northwestern University ( Andrew M Naidech )
Study ID Numbers:	1507-009
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751634
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

subarachnoid hemorrhage

intracerebral hemorrhage

fever

Study placed in the following topic categories:

Fever

Signs and Symptoms

Cerebral Hemorrhage

Vascular Diseases

Subarachnoid Hemorrhage

Central Nervous System Diseases

Intracranial Hemorrhages

Brain Diseases

Hemorrhage

Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes

Nervous System Diseases

Cardiovascular Diseases

Body Temperature Changes

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Northwestern University Gaymar Industries, Inc.
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00751634