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Management Practices and the Risk of Infection Following Cardiac Surgery

4 april 2014 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

5158

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

Inclusion Criteria:

Clinical indication for cardiac surgical interventions
Age ≥ 18 years

Exclusion Criteria:

Active systemic infection at the time of enrollment

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Icahn School of Medicine at Mount Sinai

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

Canadian Institutes of Health Research (CIHR)

National Institute of Neurological Disorders and Stroke (NINDS)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Cardiothoracic Surgical Trials Network

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 september 2011

Avslutad studie (Faktisk)

1 mars 2013

Studieregistreringsdatum

Först inskickad

17 mars 2010

Först inskickad som uppfyllde QC-kriterierna