Management Practices and the Risk of Infection Following Cardiac Surgery
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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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, Spojené státy, 30383
- Emory University
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Maryland
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Bethesda, Maryland, Spojené státy, 20892
- NIH Heart Center at Suburban Hospital
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New York
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Bronx, New York, Spojené státy, 10467
- Montefiore Einstein Heart Center
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New York, New York, Spojené státy, 10032
- Columbia University Medical Center
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North Carolina
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Durham, North Carolina, Spojené státy, 27710
- Duke University
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Greenville, North Carolina, Spojené státy, 27834
- East Carolina Heart Institute
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- University of Pennsylvania
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- University of Virginia
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Clinical indication for cardiac surgical interventions
- Age ≥ 18 years
Exclusion Criteria:
- Active systemic infection at the time of enrollment
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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The primary endpoint will be major infection within 60 days of index cardiac surgical intervention.
Časové okno: 60 Days
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60 Days
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
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Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission.
Časové okno: 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
Časové okno: 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
Časové okno: 60 Days
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60 Days
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Re-operation within 60 days of index cardiac surgical intervention
Časové okno: 60 Days
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60 Days
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Survival, All-cause mortality, Hospitalizations, Economic Measures
Časové okno: 60 Days
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60 Days
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Timothy Gardner, MD, Christiana Care Health Services
- Studijní židle: Patrick O'Gara, MD, Brigham and Women's Hospital
- Vrchní vyšetřovatel: Annetine Gelijns, Ph.D., Icahn School of Medicine at Mount Sinai
Publikace a užitečné odkazy
Obecné publikace
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GCO 08-1078-00005
- 5U01HL088942 (Grant/smlouva NIH USA)
- 5U1HL088942-02
- 694 (Jiný identifikátor: Ct Surgery Network Research Group)
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