Temperature Control in Central Fever in the Neuro-ICU

This study is currently recruiting participants.

Verified by Northwestern University, January 2009

First Received: September 10, 2008 Last Updated: January 10, 2009 History of Changes

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

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 ]
Arrhythmia [ Time Frame: Six hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 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	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

No publications provided

Responsible Party:	Northwestern University ( Andrew M Naidech )
Study ID Numbers:	1507-009
Study First Received:	September 10, 2008
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00751634 History of Changes
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:

Fever
Signs and Symptoms
Pathologic Processes
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Body Temperature Changes
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009