Management Practices and the Risk of Infection Following Cardiac Surgery

Completed

• Conditions: Postoperative Wound Infection; Cardiac Surgery; Infection, Postoperative Wound; Infections, Nosocomial; Management Practices

• Registration Number: NCT01089712
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Primary Completion: 2011-09
• Study Completion: 2013-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5158

Inclusion Criteria

• Clinical indication for cardiac surgical interventions
• Age ≥ 18 years

Exclusion Criteria

• Active systemic infection at the time of enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be major infection within 60 days of index cardiac surgical intervention.	60 Days

Secondary Outcome Measures

Name	Time	Method
Re-operation within 60 days of index cardiac surgical intervention	60 Days
Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission.	30 Days
Survival, All-cause mortality, Hospitalizations, Economic Measures	60 Days
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
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

Trial Locations

Locations (10)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

Montefiore Einstein Heart Center; 🇺🇸 Bronx, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

East Carolina Heart Institute; 🇺🇸 Greenville, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

NIH Heart Center at Suburban Hospital; 🇺🇸 Bethesda, Maryland, United States