Management Practices and the Risk of Infection Following Cardiac Surgery

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01089712
First received: March 17, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition
Cardiac Surgery
Infection, Postoperative Wound
Postoperative Wound Infection
Infections, Nosocomial
Management Practices

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Management Practices and the Risk of Infection Following Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • The primary endpoint will be major infection within 60 days of index cardiac surgical intervention. [ Time Frame: 60 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
  • Other infections within 60 days of index cardiac surgical intervention; Superficial incisional surgical site infection (primary/secondary); Symptomatic urinary tract infection; Asymptomatic bacteriuria [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
  • Re-operation within 60 days of index cardiac surgical intervention [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
  • Survival, All-cause mortality, Hospitalizations, Economic Measures [ Time Frame: 60 Days ] [ Designated as safety issue: No ]

Enrollment: 5158
Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing cardiac surgery
The patient population for this study consists of all patients undergoing cardiac surgical interventions. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients undergoing cardiac surgical interventions at the 10 CT Surgery Network institutions

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Active systemic infection at the time of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089712

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30383
United States, Maryland
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States, 20892
United States, New York
Montefiore Einstein Heart Center
Bronx, New York, United States, 10467
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
East Carolina Heart Institute
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Mount Sinai School of Medicine
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Timothy Gardner, MD Christiana Care Health Services
Study Chair: Patrick O'Gara, MD Brigham and Women's Hospital
Principal Investigator: Annetine Gelijns, Ph.D. Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01089712     History of Changes
Other Study ID Numbers: GCO 08-1078-00005, 5U01HL088942, 5U1HL088942-02, 694
Study First Received: March 17, 2010
Last Updated: April 4, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by Mount Sinai School of Medicine:
Infection
Cardiac Surgery
Post Operative Cardiac Surgery Infection
Management Practices

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Cross Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014