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| Name | Class |
|---|---|
| Cheetah Medical Inc. | INDUSTRY |
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This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard intraoperative care- no interventions | Active Comparator | Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions |
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| RESIPI | Experimental | Intraoperative implementation of RESIPI management strategy, a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESIPI Management Strategy | Procedure | a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical, Inc). |
| Measure | Description | Time Frame |
|---|---|---|
| B-typer Natriuretic Peptide (BNP) | Change in BNP (>250 ng/ml) | Post Op day 1 |
| Troponin | Change in troponin (>=0.04%) | Post Op day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30 days post op | |
| Major cardiac events | Occurrence of major cardiac events (new arrhythmia, myocardial ischemia/infarction, congestive heart failure, or in-hospital cardiac arrest) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew D McEvoy, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| No intervention | Other | No intervention |
|
| 30 days post op |
| Hospital length of stay | Approximately 3-5 days |
| Readmission rate (Emergency room or hospital) | 30 days post operative |
| Return to operating room | 30 days post operative |
| Total hospital cost | 30 days post operative |
| Occurrence of significant medical events | Occurrence of significant medical events (stroke, delirium, pneumonia, new oxygen requirement, need for re-intubation, acute kidney injury (KDIGO criteria), hyperglycemia (glucose >180) | 30 days post operative |
| Days at home in first 30 days | 30 days post operative |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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