Temperature Control in Central Fever in the Neuro-ICU

Fever Clinical Trial

Official title:

Temperature Control in Central Fever in the Neuro-ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751634
• Other study ID #: 1507-009
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2008
• Last updated: April 30, 2013
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: April 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Hemorrhage
• Cerebral Hemorrhage
• Fever
• Hemorrhage

Intervention

Device:
• Gaymar Rapr-Round (external cooling blanket)
Application of the device per its approved labeling

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Gaymar Industries, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care	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.	baseline, one, two and six hours after application.	No
Secondary	Time From Start of Cooling Device to Core Temperature < 100.4F	For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F	Six hours	No
Secondary	Number of Participants With Severe Shivering	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	six hours	Yes
Secondary	Number of Participants With Hypotension	New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period	six hours	Yes
Secondary	Number of Participants With Arrhythmia	New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm	Six hours	Yes