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.
Status | Completed |
Enrollment | 5158 |
Est. completion date | March 2013 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical indication for cardiac surgical interventions - Age = 18 years Exclusion Criteria: - Active systemic infection at the time of enrollment |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montreal | Quebec |
United States | Emory University | Atlanta | Georgia |
United States | NIH Heart Center at Suburban Hospital | Bethesda | Maryland |
United States | Montefiore Einstein Heart Center | Bronx | New York |
United States | University of Virginia | Charlottesville | Virginia |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Duke University | Durham | North Carolina |
United States | East Carolina Heart Institute | Greenville | North Carolina |
United States | Columbia University Medical Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Canadian Institutes of Health Research (CIHR), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint will be major infection within 60 days of index cardiac surgical intervention. | 60 Days | No | |
Secondary | Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission. | 30 Days | No | |
Secondary | Other infections within 60 days of index cardiac surgical intervention; Superficial incisional surgical site infection (primary/secondary); Symptomatic urinary tract infection; Asymptomatic bacteriuria | 60 Days | No | |
Secondary | Non-infection adverse events within 60 days of index cardiac surgical intervention; Neurologic Dysfunction; Transient ischemic attack; cerebrovascular accident (ischemic or hemorrhagic stroke); Myocardial infarction | 60 Days | No | |
Secondary | Re-operation within 60 days of index cardiac surgical intervention | 60 Days | No | |
Secondary | Survival, All-cause mortality, Hospitalizations, Economic Measures | 60 Days | No |
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