Management Practices and the Risk of Infection Following Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Management Practices and the Risk of Infection Following Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089712
• Other study ID #: GCO 08-1078-00005
• Secondary ID: 5U01HL0889425U1H
• Status: Completed
• Phase: N/A
• First received: March 17, 2010
• Last updated: April 4, 2014
• Start date: January 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardCanada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgery
• Communicable Diseases
• Cross Infection
• Infection
• Infection, Postoperative Wound
• Infections, Nosocomial
• Management Practices
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection

Locations

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

Sponsors (4)

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)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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

External Links

•   Cardiothoracic Surgical Trials Network