The Epidemiology of Ventricular Assist Device-Related Infections

November 15, 2011 updated by: 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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of suspected infections, characterized by infecting organism and location.
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect and quantify culture results for suspected infections and the secondary manifestations of infection
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Parides, PhD, Icahn School of Medicine at Mount Sinai
  • Study Director: Patrice Desvigne-Nickens, National Heart, Lung, and Blood Institute (NHLBI)
  • Study Chair: Yoshifumi Naka, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 08-1093 HP
  • 5P50HL077096 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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