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Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.
This is a randomized device efficacy trial. Patients with a supratentorial intracerebral hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads applied to the torso and thighs for five days. The Arctic Sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. Patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS), telemetry monitoring and labs will also be performed daily. The investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arctic Sun cooling device | Experimental | The Arctic Sun device pads will be placed on the patient as per manufacturer's instructions. Patients, who cannot tolerate placement of all the pads for any given reason, will still be included in the study if they can maintain normothermia (normal body temperature). The total normothermia time for the study is five days. After 5 days, the attending physician will make clinical decisions based on the patient needs.The temperature goal for this study is 36.5 degree Celsius, but normothermia for the purpose of this study will be defined as a temperature of 35.5 - 37.5 degree Celsius. A thermometer mounted urinary catheter will be used for temperature monitoring and feedback to the Arctic Sun. |
|
| Standard of Care | Active Comparator | Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician) initiated at a temperature of 38.5 degrees Celsius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Sun cooling device | Device | The Arctic SunĀ® 5000 Temperature management systems (Bard Medical), a non- invasive, surface cooling technology that allows rapid and precise manipulation of core body temperature will be employed to maintain normothermia (normal temperature) in patients with ICH randomized to the treatment group. |
| Measure | Description | Time Frame |
|---|---|---|
| MRI measurement of relative perihematomal edema (% change of perihematomal edema) | Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI | First 5 days of hospital course |
| Measure | Description | Time Frame |
|---|---|---|
| Structured telephone interview of functional and cognitive outcome | Functional and cognitive outcomes measured by structured phone assessment. | 3 months and 1 year |
| Serum cytokine measurement with inflammatory cytokine protein array |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cytokine measurement with inflammatory cytokine protein array in control ICH patients | Cytokine markers of inflammation tested daily over the first five days of the study in control ICH patients to determine the natural inflammation history of ICH. | 5 days |
| Diagnosis of Pneumonia/Sepsis/Adult Respiratory Distress Syndrome (ARDS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier J Provencio, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician) |
|
Cytokine markers of inflammation tested daily over the first 5 days.
| 5 days |
Berlin classification for mild adult respiratory distress syndrome (previously ALI) and adult respiratory distress syndrome (ARDS). Centers for Disease Control and Prevention (CDC) definitions for pneumonia and sepsis. |
| First 10 days of hospital stay |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |