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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


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
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