NCT01089712|CompletedDMC
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Sponsor study identifier
Secondary identifiers
observational
5,158
2 countries
10
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
March 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 17, 2010
Actual (reported)March 18, 2010
Actual (reported)September 2011
Actual (reported)March 2013
Actual (reported)The primary endpoint will be major infection 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
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
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.
All patients undergoing cardiac surgical interventions at the 10 CT Surgery Network institutions
Emory University
Atlanta, Georgia, 30383, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, 20892, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Einstein Heart Center
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
East Carolina Heart Institute
Greenville, North Carolina, 27834, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Greco G, Shi W, Michler RE, Meltzer DO, Ailawadi G, Hohmann SF, Thourani VH, Argenziano M, Alexander JH, Sankovic K, Gupta L, Blackstone EH, Acker MA, Russo MJ, Lee A, Burks SG, Gelijns AC, Bagiella E, Moskowitz AJ, Gardner TJ. Costs associated with health care-associated infections in cardiac surgery. J Am Coll Cardiol. 2015 Jan 6;65(1):15-23. doi: 10.1016/j.jacc.2014.09.079.
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.
Timothy Gardner, MD
Christiana Care Health Services
Patrick O'Gara, MD
Brigham and Women's Hospital
Annetine Gelijns, Ph.D.
Icahn School of Medicine at Mount Sinai
5,158 participants (actual enrollment reported by the registry).
First Submitted
March 17, 2010
First Posted
March 18, 2010
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Transfusion Requirements in Cardiac Surgery
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
Re-operation within 60 days of index cardiac surgical intervention
60 Days
Survival, All-cause mortality, Hospitalizations, Economic Measures
60 Days
Contact the study team to confirm eligibility.
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Primary Completion
September 2011
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
April 8, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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