Brain Hemorrhage, Fever
Conditions
Keywords
subarachnoid hemorrhage, intracerebral hemorrhage, fever
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.
Interventions
DEVICEGaymar Rapr-Round (external cooling blanket)
Application of the device per its approved labeling
Sponsors
Gaymar Industries, Inc.
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Application of the Gaymar Rapr-Round device per FDA-approved use (temperature reduction in patients with fever in a monitored setting) | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age Continuous | 54.3 years STANDARD_DEVIATION 15.4 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 4 / 20 |
Outcome results
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.
Time frame: baseline, one, two and six hours after application.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group at 0, 1, 2, 6 Hours | Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care | 0 hours | 100.8 degrees F | Standard Deviation 0.4 |
| Treatment Group at 0, 1, 2, 6 Hours | Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care | 1 hour | 100.3 degrees F | Standard Deviation 0.9 |
| Treatment Group at 0, 1, 2, 6 Hours | Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care | 2 hours | 99.9 degrees F | Standard Deviation 1.1 |
| Treatment Group at 0, 1, 2, 6 Hours | Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care | 6 hours | 99.5 degrees F | Standard Deviation 0.7 |
Secondary
Number of Participants With Arrhythmia
New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm
Time frame: Six hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group at 0, 1, 2, 6 Hours | Number of Participants With Arrhythmia | 0 participants |
Secondary
Number of Participants With Hypotension
New systolic blood pressure \< 100 mm Hg, or new vasopressor use during study period
Time frame: six hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group at 0, 1, 2, 6 Hours | Number of Participants With Hypotension | 0 participants |
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 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
Population: All participants were analyzed for the outcome of BSAS=3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Group at 0, 1, 2, 6 Hours | Number of Participants With Severe Shivering | 4 participants |
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
Time frame: Six hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group at 0, 1, 2, 6 Hours | Time From Start of Cooling Device to Core Temperature < 100.4F | 2.1 hours | Standard Deviation 1.6 |