Management Practices and the Risk of Infection Following Cardiac Surgery
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Montreal, Quebec, Canadá, H1T 1C8
- Montreal Heart Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30383
- Emory University
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892
- NIH Heart Center at Suburban Hospital
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New York
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Bronx, New York, Estados Unidos, 10467
- Montefiore Einstein Heart Center
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New York, New York, Estados Unidos, 10032
- Columbia University Medical center
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University
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Greenville, North Carolina, Estados Unidos, 27834
- East Carolina Heart Institute
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Clinical indication for cardiac surgical interventions
- Age ≥ 18 years
Exclusion Criteria:
- Active systemic infection at the time of enrollment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The primary endpoint will be major infection within 60 days of index cardiac surgical intervention.
Periodo de tiempo: 60 Days
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60 Days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 60 Days
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60 Days
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Re-operation within 60 days of index cardiac surgical intervention
Periodo de tiempo: 60 Days
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60 Days
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Survival, All-cause mortality, Hospitalizations, Economic Measures
Periodo de tiempo: 60 Days
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60 Days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Timothy Gardner, MD, Christiana Care Health Services
- Silla de estudio: Patrick O'Gara, MD, Brigham and Women's Hospital
- Investigador principal: Annetine Gelijns, Ph.D., Icahn School Of Medicine At Mount Sinai
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GCO 08-1078-00005
- 5U01HL088942 (Subvención/contrato del NIH de EE. UU.)
- 5U1HL088942-02
- 694 (Otro identificador: Ct Surgery Network Research Group)
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