Temperature Control in Central Fever in the Neuro-ICU

Northwestern University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fever Brain Hemorrhage

Interventions

Gaymar Rapr-Round (external cooling blanket)DEVICE

Application of the device per its approved labeling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline, one, two and six hours after application.

Secondary Outcomes

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

Time frame: Six hours

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 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

Time frame: six hours

Number of Participants With Hypotension

New systolic blood pressure \< 100 mm Hg, or new vasopressor use during study period

Time frame: six hours

Number of Participants With Arrhythmia

New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm

Time frame: Six hours

Data from ClinicalTrials.gov

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