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Management Practices and the Risk of Infection Following Cardiac Surgery

4 avril 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

5158

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

Inclusion Criteria:

Clinical indication for cardiac surgical interventions
Age ≥ 18 years

Exclusion Criteria:

Active systemic infection at the time of enrollment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Délai
The primary endpoint will be major infection within 60 days of index cardiac surgical intervention. Délai: 60 Days	60 Days

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Icahn School of Medicine at Mount Sinai

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)

Canadian Institutes of Health Research (CIHR)

National Institute of Neurological Disorders and Stroke (NINDS)

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Cardiothoracic Surgical Trials Network

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 septembre 2011

Achèvement de l'étude (Réel)

1 mars 2013

Dates d'inscription aux études

Première soumission

17 mars 2010

Première soumission répondant aux critères de contrôle qualité