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The Epidemiology of Ventricular Assist Device-Related Infections

15. november 2011 oppdatert av: Icahn School of Medicine at Mount Sinai

Infections often occur after ventricular assist devices (VADs) are placed. These infections can be very serious. The goal of this study is to understand why these infections occur. Bacteria (germs) normally live on our skin and in our noses. After surgery, they can infect the VAD. The investigators will collect cultures of your skin and nose before and after surgery. The investigators will compare these bacteria to bacteria that cause infections. Their genes will be compared to see which ones help the bacteria cause infection.

Studieoversikt

Status

Fullført

Forhold

Kongestiv hjertesvikt

Detaljert beskrivelse

Infections are one of the most serious of ventricular assist device (VAD) related complications. Many of these infections are associated with significant patient morbidity and mortality. Diagnosis of these infections is often difficult due to the complicated nature of the patient's medical problems, the need for rapid institution of empiric antibiotic therapy and the lack of established criteria that define infection. Staphylococci are among the most common causes of VAD infections. The basis for this high incidence is not well understood but is believed to be in part due to inoculation of staphylococcal commensal flora into wound sites at the time of surgery or thereafter. The goals of this observational study are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD related infection.

This is a prospective, multi-center, observational study to identify risk factors associated with the development of VAD-related infections. Patients will be followed for up to one year following VAD implantation, time of death or transplantation, whichever comes first. There will be no randomization for this observational study.

Studietype

Observasjonsmessig

Registrering (Faktiske)

150

Kontakter og plasseringer

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

Studiesteder

Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35294
    - University of Alabama at Birmingham
- California
  - San Diego, California, Forente stater, 92123
    - Sharp Memorial Hospital
- Illinois
  - Oak Lawn, Illinois, Forente stater, 60453
    - Advocate Christ Medical Center
- Kentucky
  - Louisville, Kentucky, Forente stater, 40202
    - Jewish Hospital
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48109
    - University of Michigan
- Minnesota
  - Minneapolis, Minnesota, Forente stater, 55455
    - University of Minnesota
- New York
  - Bronx, New York, Forente stater, 10467
    - Montefiore Medical Center
  - New York, New York, Forente stater, 10032
    - Columbia Presbyterian Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, Forente stater, 19104
    - Hospital of the University of Pennsylvania
- Utah
  - Salt Lake City, Utah, Forente stater, 84143
    - LDS Hospital
- Washington
  - Spokane, Washington, Forente stater, 99204
    - Sacred Heart Medical Center
- Wisconsin
  - Madison, Wisconsin, Forente stater, 53792
    - University of Wisconsin Hospital
  - Milwaukee, Wisconsin, Forente stater, 53215
    - St. Luke's Medical Center

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

Sannsynlighetsprøve

Studiepopulasjon

Patients with end-stage heart failure who demonstrate the need for intermediate or long-term support with a VAD.

Beskrivelse

Inclusion Criteria:

Age greater than or equal to 18 years.
Approved by the institution's heart failure/transplant committee for VAD implantation, either as a bridge to cardiac transplantation or for destination therapy for end-stage heart failure.
Signed informed consent, release of medical information, and HIPAA forms.
Expectation of compliance with protocol procedures and study visit schedule.

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
Study Population 150 subjects with end-stage heart failure who have been scheduled to undergo device implantation with a VAD, either as a bridge to cardiac transplantation or for destination therapy.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
The incidence of suspected infections, characterized by infecting organism and location. Tidsramme: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.	The primary goal is to collect information that describes infections in patients receiving LVADs.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Collect and quantify culture results for suspected infections and the secondary manifestations of infection Tidsramme: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.	Bacteria normally live on our skin and in our noses.After surgery, they can infect the VAD. We will collect cultures before and after surgery and compare these bacteria to bacteria that cause infections.Their genes will be compared to see which ones help the bacteria cause infection. We hope this will help develop new ways to help prevent VAD infections.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Develop Guidelines to properly diagnose VAD infections Tidsramme: Up to one year following VAD implantation, time of death or transplantation, whichever comes first.	Information will be collected on patient's medical condition after surgery including blood tests to help determine if an infection is present.	Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Costs (direct) Tidsramme: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.	The value of all resources that are consumed in the provision of an intervention or dealing with the side-effects or other current and future consequences linked to it.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Adverse Events Tidsramme: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.	Since this is an observational study there will be no adverse events directly attributable to a study intervention. However, adverse events that might potentially contribute to the risk or course of VAD-related infections will be monitored.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.

Samarbeidspartnere og etterforskere

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Sponsor

Icahn School of Medicine at Mount Sinai

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Etterforskere

Hovedetterforsker: Michael Parides, PhD, Icahn School of Medicine at Mount Sinai
Studieleder: Patrice Desvigne-Nickens, National Heart, Lung, and Blood Institute (NHLBI)
Studiestol: Yoshifumi Naka, MD, Columbia University

Publikasjoner og nyttige lenker

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Generelle publikasjoner

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 2006

Primær fullføring (Faktiske)

1. januar 2009

Studiet fullført (Faktiske)