- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01089712
Management Practices and the Risk of Infection Following Cardiac Surgery
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Quebec
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Montreal, Quebec, Kanada, H1T 1C8
- Montreal Heart Institute
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30383
- Emory University
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20892
- NIH Heart Center at Suburban Hospital
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New York
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Bronx, New York, Vereinigte Staaten, 10467
- Montefiore Einstein Heart Center
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New York, New York, Vereinigte Staaten, 10032
- Columbia University Medical Center
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University
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Greenville, North Carolina, Vereinigte Staaten, 27834
- East Carolina Heart Institute
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- University of Pennsylvania
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Virginia
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Charlottesville, Virginia, Vereinigte Staaten, 22908
- University of Virginia
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Clinical indication for cardiac surgical interventions
- Age ≥ 18 years
Exclusion Criteria:
- Active systemic infection at the time of enrollment
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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The primary endpoint will be major infection within 60 days of index cardiac surgical intervention.
Zeitfenster: 60 Days
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60 Days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission.
Zeitfenster: 30 Days
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30 Days
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Other infections within 60 days of index cardiac surgical intervention; Superficial incisional surgical site infection (primary/secondary); Symptomatic urinary tract infection; Asymptomatic bacteriuria
Zeitfenster: 60 Days
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60 Days
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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
Zeitfenster: 60 Days
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60 Days
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Re-operation within 60 days of index cardiac surgical intervention
Zeitfenster: 60 Days
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60 Days
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Survival, All-cause mortality, Hospitalizations, Economic Measures
Zeitfenster: 60 Days
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60 Days
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Timothy Gardner, MD, Christiana Care Health Services
- Studienstuhl: Patrick O'Gara, MD, Brigham and Women's Hospital
- Hauptermittler: Annetine Gelijns, Ph.D., Icahn School of Medicine at Mount Sinai
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GCO 08-1078-00005
- 5U01HL088942 (US NIH Stipendium/Vertrag)
- 5U1HL088942-02
- 694 (Andere Kennung: Ct Surgery Network Research Group)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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