- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01089712
Management Practices and the Risk of Infection Following Cardiac Surgery
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Quebec
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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Georgia
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Atlanta, Georgia, Stati Uniti, 30383
- Emory University
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892
- NIH Heart Center at Suburban Hospital
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New York
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Bronx, New York, Stati Uniti, 10467
- Montefiore Einstein Heart Center
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New York, New York, Stati Uniti, 10032
- Columbia University Medical Center
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University
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Greenville, North Carolina, Stati Uniti, 27834
- East Carolina Heart Institute
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Clinical indication for cardiac surgical interventions
- Age ≥ 18 years
Exclusion Criteria:
- Active systemic infection at the time of enrollment
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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The primary endpoint will be major infection within 60 days of index cardiac surgical intervention.
Lasso di tempo: 60 Days
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60 Days
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 60 Days
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60 Days
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Re-operation within 60 days of index cardiac surgical intervention
Lasso di tempo: 60 Days
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60 Days
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Survival, All-cause mortality, Hospitalizations, Economic Measures
Lasso di tempo: 60 Days
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60 Days
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Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Timothy Gardner, MD, Christiana Care Health Services
- Cattedra di studio: Patrick O'Gara, MD, Brigham and Women's Hospital
- Investigatore principale: Annetine Gelijns, Ph.D., Icahn School of Medicine at Mount Sinai
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GCO 08-1078-00005
- 5U01HL088942 (Sovvenzione/contratto NIH degli Stati Uniti)
- 5U1HL088942-02
- 694 (Altro identificatore: Ct Surgery Network Research Group)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Chirurgia cardiaca
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