Cardiac Surgery Clinical Trial
Official title:
Management Practices and the Risk of Infection Following Cardiac Surgery
The purpose of the study is to determine the best ways to prevent infections after heart surgery. Participation in the study will last at most 3 months after heart surgery. The study will only collect information about the care patients receive during the planned surgery. No new testing or procedures will be done. Patients will receive only the tests or procedures the doctor already has planned. This kind of study is an observational study, because all that is planned to do is observe the care patients receive and how well they do during treatment. The information collected should help to improve the quality of surgical care in the future.
Hospital-acquired infections represent the main non-cardiac complication after heart
surgery. They are associated with substantial morbidity and higher mortality, as they often
require prolonged hospitalization and additional surgery. The proportion of cardiac surgery
patients at high-risk for infection is increasing because of the increased prevalence of
co-morbid conditions such as obesity and diabetes mellitus in the general (and especially
the elderly) population.
In addition to increased morbidity and mortality, infectious complications also result in
greater economic burden. A past study estimated that the incremental cost of treating
Medicare beneficiaries who suffered from septicemia after coronary artery bypass grafting
(CABG) to be $59,204. These patients stayed in the hospital 21.3 days longer than those who
did not experience any serious adverse events. Of great relevance to treating hospitals, the
Centers for Medicare and Medicaid Services (CMS) announced in the fall of 2007 that they
would no longer pay for care related to preventable complications. CMS specifically
mentioned excluding reimbursements for mediastinitis after CABG, and catheter associated
infections. Thus, there is a crucial need to identify variables that mitigate infections
post cardiac surgery and to develop effective preventative treatment strategies.
Prior studies have examined the relationship between patient baseline (preoperative)
characteristics (e.g., co-morbid conditions) and hospital-acquired infections post cardiac
surgery. The STS database, for example, has led to the identification of predictive factors
of post-operative CABG infections. Much of the variations in outcomes seen at different
institutions, however, cannot be explained by differences in preoperative patient
characteristics alone. How care is delivered also plays an essential role in determining
infection rates and is therefore likely to explain some of the differences in these rates
observed at different institutions. The literature has not sufficiently examined the
relationship between treatment/management practices (e.g., line management, ventilator
management, etc) and postoperative infection risk. In this study we seek to better
understand management practices that put patients at high risk for infections post-cardiac
surgery.
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Observational Model: Case-Only, Time Perspective: Prospective
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