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Management Practices and the Risk of Infection Following Cardiac Surgery

4 april 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

5158

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

Inclusion Criteria:

Clinical indication for cardiac surgical interventions
Age ≥ 18 years

Exclusion Criteria:

Active systemic infection at the time of enrollment

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Icahn School of Medicine at Mount Sinai

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

Canadian Institutes of Health Research (CIHR)

National Institute of Neurological Disorders and Stroke (NINDS)

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Cardiothoracic Surgical Trials Network

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2010

Primaire voltooiing (Werkelijk)

1 september 2011

Studie voltooiing (Werkelijk)

1 maart 2013

Studieregistratiedata

Eerst ingediend

17 maart 2010

Eerst ingediend dat voldeed aan de QC-criteria