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Completed

NCT Number: NCT01471795

The Epidemiology of Ventricular Assist Device-Related Infections

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 16, 2011
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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