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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.
The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | In this group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. |
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| 2 | Experimental | In this group (High), the goal was to maintain MAP between 80-100 mm Hg during CPB. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regulating Mean Arterial Pressure during cardiopulmonary bypass | Procedure | Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac morbidity | 6-months after surgery | |
| Neurologic morbidity | 6-months after surgery | |
| Mortality | 6-months after surgery | |
| Functional status | 6-months after surgery | |
| Neurocognitive function | 6-months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E Charlson, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital-Weill Cornell Medical College | New York | New York | 10065 | United States |
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