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The Epidemiology of Ventricular Assist Device-Related Infections

15. november 2011 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

  1. Age greater than or equal to 18 years.
  2. 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.
  3. Signed informed consent, release of medical information, and HIPAA forms.
  4. Expectation of compliance with protocol procedures and study visit schedule.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Icahn School of Medicine at Mount Sinai

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

  • Ledende efterforsker: 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

7. november 2011

Først indsendt, der opfyldte QC-kriterier

15. november 2011

Først opslået (Skøn)

16. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. november 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. november 2011

Sidst verificeret

1. november 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 08-1093 HP
  • 5P50HL077096 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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