Temperature Control in Central Fever in the Neuro-ICU

• ClinicalTrials.gov Identifier: NCT00751634
• Recruitment Status: Completed
• First Posted: September 12, 2008
• Results First Posted: April 9, 2012
• Last Update Posted: May 6, 2013
• Sponsor: Northwestern University
• Collaborator: Gaymar Industries, Inc.
• Information provided by (Responsible Party): Andrew Naidech, Northwestern University

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 (Clinical Trial)
• 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: January 2009
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

   1. Mild: shivering localized to the neck and/or thorax only
   2. Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)
   3. Severe: shivering involves gross movements of the trunk and upper and lower extremities
3. Number of Participants With Hypotension [ Time Frame: six hours ]
   New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period
4. Number of Participants With Arrhythmia [ Time Frame: Six hours ]
   New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 [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

United States, Illinois

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

More Information

• Responsible Party: Andrew Naidech, Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT00751634
• Other Study ID Numbers: 1507-009
• First Posted: September 12, 2008
• Results First Posted: April 9, 2012
• Last Update Posted: May 6, 2013
• Last Verified: April 2013

Keywords provided by Andrew Naidech, Northwestern University:

subarachnoid hemorrhage; intracerebral hemorrhage; fever

Additional relevant MeSH terms:

Intracranial Hemorrhages; Hemorrhage; Fever; Pathologic Processes; Body Temperature Changes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases