Management Practices and the Risk of Infection Following Cardiac Surgery

NCT01089712 | Completed DMC

• 4 other identifiers: GCO 08-1078-000055U01HL0889425U1HL088942-02694
• Study Type: observational
• Target: 5,158
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

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

Keywords

Infection; Cardiac Surgery; Post Operative Cardiac Surgery Infection; Management Practices

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be major infection within 60 days of index cardiac surgical intervention.

  60 Days

Secondary Outcomes (5)

• 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

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Active systemic infection at the time of enrollment

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (10)

Emory University

Atlanta, Georgia, 30383, United States

Location

NIH Heart Center at Suburban Hospital

Bethesda, Maryland, 20892, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Einstein Heart Center

The Bronx, New York, 10467, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

East Carolina Heart Institute

Greenville, North Carolina, 27834, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (2)

• 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.

  PMID: 25572505 DERIVED

• 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.

  PMID: 25060372 DERIVED

Related Links

• Cardiothoracic Surgical Trials Network

MeSH Terms

Conditions

Surgical Wound Infection; Cross Infection; Infections

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes

Study Officials

• Timothy Gardner, MD

  Christiana Care Health Services

  STUDY CHAIR

• Patrick O'Gara, MD

  Brigham and Women's Hospital

  STUDY CHAIR

• Annetine Gelijns, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2013
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

CA (1); US (9)