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The Epidemiology of Ventricular Assist Device-Related Infections

15 november 2011 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Hjärtsvikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

150

Kontakter och platser

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

Studieorter

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

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

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

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
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
The incidence of suspected infections, characterized by infecting organism and location. Tidsram: 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.

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Collect and quantify culture results for suspected infections and the secondary manifestations of infection Tidsram: 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 Tidsram: 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) Tidsram: 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 Tidsram: 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.

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)

Utredare

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

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

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 2006

Primärt slutförande (Faktisk)

1 januari 2009

Avslutad studie (Faktisk)