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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

March 17, 2010
April 4, 2014
January 2010
September 2011   (final data collection date for primary outcome measure)
The primary endpoint will be major infection within 60 days of index cardiac surgical intervention. [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01089712 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Management Practices and the Risk of Infection Following Cardiac Surgery
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Cardiac Surgery
  • Infection, Postoperative Wound
  • Postoperative Wound Infection
  • Infections, Nosocomial
  • Management Practices
Not Provided
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.
Gelijns AC, Moskowitz AJ, Acker MA, Argenziano M, Geller NL, Puskas JD, Perrault LP, Smith PK, Kron IL, Michler RE, Miller MA, Gardner TJ, Ascheim DD, Ailawadi G, Lackner P, Goldsmith LA, Robichaud S, Miller RA, Rose EA, Ferguson TB Jr, Horvath KA, Moquete EG, Parides MK, Bagiella E, O'Gara PT, Blackstone EH; Cardiothoracic Surgical Trials Network (CTSN). Management practices and major infections after cardiac surgery. J Am Coll Cardiol. 2014 Jul 29;64(4):372-81. doi: 10.1016/j.jacc.2014.04.052.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5158
March 2013
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Active systemic infection at the time of enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01089712
GCO 08-1078-00005, 5U01HL088942, 5U1HL088942-02, 694
Yes
Mount Sinai School of Medicine
Mount Sinai School of Medicine
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Canadian Institutes of Health Research (CIHR)
  • National Institute of Neurological Disorders and Stroke (NINDS)
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
Mount Sinai School of Medicine
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP