Temperature Control in Central Fever in the Neuro-ICU

Phase 4

Completed

• Conditions: Fever; Brain Hemorrhage
• Interventions: Device: Gaymar Rapr-Round (external cooling blanket)

• Registration Number: NCT00751634
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-10
• Study First Posted: 2008-09-12
• Study Start: 2009-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-01-09
• Results First Submitted QC: 2012-03-13
• Results First Posted: 2012-04-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-30
• Last Update Posted: 2013-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Gaymar Rapr-Round (external cooling blanket)	Application of the Gaymar Rapr-Round device per approved use

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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; 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
Number of Participants With Hypotension	six hours	New systolic blood pressure \< 100 mm Hg, or new vasopressor use during study period
Number of Participants With Arrhythmia	Six hours	New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States