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Management Practices and the Risk of Infection Following Cardiac Surgery

4. april 2014 oppdatert av: Icahn School of Medicine at Mount Sinai

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

5158

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Canada
- Quebec
  - Montreal, Quebec, Canada, H1T 1C8
    - Montreal Heart Institute
Forente stater
- Georgia
  - Atlanta, Georgia, Forente stater, 30383
    - Emory University
- Maryland
  - Bethesda, Maryland, Forente stater, 20892
    - NIH Heart Center at Suburban Hospital
- New York
  - Bronx, New York, Forente stater, 10467
    - Montefiore Einstein Heart Center
  - New York, New York, Forente stater, 10032
    - Columbia University Medical Center
- North Carolina
  - Durham, North Carolina, Forente stater, 27710
    - Duke University
  - Greenville, North Carolina, Forente stater, 27834
    - East Carolina Heart Institute
- Ohio
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic Foundation
- Pennsylvania
  - Philadelphia, Pennsylvania, Forente stater, 19104
    - University of Pennsylvania
- Virginia
  - Charlottesville, Virginia, Forente stater, 22908
    - University of Virginia

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

Clinical indication for cardiac surgical interventions
Age ≥ 18 years

Exclusion Criteria:

Active systemic infection at the time of enrollment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
The primary endpoint will be major infection within 60 days of index cardiac surgical intervention. Tidsramme: 60 Days	60 Days

Sekundære resultatmål

Resultatmål	Tidsramme
Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission. Tidsramme: 30 Days	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 Tidsramme: 60 Days	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 Tidsramme: 60 Days	60 Days
Re-operation within 60 days of index cardiac surgical intervention Tidsramme: 60 Days	60 Days
Survival, All-cause mortality, Hospitalizations, Economic Measures Tidsramme: 60 Days	60 Days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Icahn School of Medicine at Mount Sinai

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Canadian Institutes of Health Research (CIHR)

National Institute of Neurological Disorders and Stroke (NINDS)

Etterforskere

Studiestol: Timothy Gardner, MD, Christiana Care Health Services
Studiestol: Patrick O'Gara, MD, Brigham and Women's Hospital
Hovedetterforsker: Annetine Gelijns, Ph.D., Icahn School of Medicine at Mount Sinai

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Cardiothoracic Surgical Trials Network

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. september 2011

Studiet fullført (Faktiske)

1. mars 2013

Datoer for studieregistrering

Først innsendt

17. mars 2010

Først innsendt som oppfylte QC-kriteriene