Surgical myocardial revascularization is a safe, effective and well accepted treatment modality for severe coronary artery disease. Only recently has the medical community begun to appreciate that major as well as relatively minor complications of the procedure may have a significant and long lasting impact on the patients functional status. The principal objective of this randomized trial is to assess the safety and efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and non-cognitive neurologic morbidity and mortality and post-operative deterioration in the functional status of patients undergoing elective coronary artery revascularization (CABG). The study is a prospective trial of 248 patients who will be evaluated pre-operatively, monitored intra-operatively and followed post-operatively according to a standardized surveillance protocol. Patients will be randomized to two forms of hemodynamic management during cardiopulmonary bypass: in one group, the intra-operative MAP will be maintained between 80-100 mm Hg; in the second group, the intra-operative MAP will be maintained between 50-60 mm Hg. Both are standard, safe approaches to management. There are five principal outcomes: total mortality at 6 months, cardiopulmonary morbidity (i.e., myocardial infarction, pulmonary edema, cardiogenic shock/low flow state), cognitive complications (defined by intra-patient deterioration on psychometric test of memory, psychomotor function, and linguistic function), neurologic complications (new focal deficits, such as hemiplegia, dysphasia, cranial nerve lesions) and functional status (using the MOS index) at 6 months post-operatively. Impairment or improvement in physical and mental function at 6 months will also be documented using patient-specific transition indices that document changes in the patient's ability to engage in their usual activities. Changes in the MOS, Beck Depression Inventory, and in life stress and social integration will be assessed at baseline, 6 and 12 months. The long-term objective is to improve the quality of life and functional status after CABG. This study will define the impact of post-operative complications on functional status and determine whether different approaches to intra-operative hemodynamic management can reduce post-operative morbidity and prevent post-operative dysfunction.
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