The Epidemiology of Ventricular Assist Device-Related Infections

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01471795
First received: November 7, 2011
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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.


Condition
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Epidemiology of Ventricular Assist Device-Related Infections

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    The primary goal is to collect information that describes infections in patients receiving LVADs.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • Develop Guidelines to properly diagnose VAD infections [ Time Frame: Up to one year following VAD implantation, time of death or transplantation, whichever comes first. ] [ Designated as safety issue: No ]
    Information will be collected on patient's medical condition after surgery including blood tests to help determine if an infection is present.

  • Costs (direct) [ Time Frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. ] [ Designated as safety issue: No ]
    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.

  • Adverse Events [ Time Frame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first. ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: January 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471795

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Study Director: Patrice Desvigne-Nickens National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Yoshifumi Naka, MD Columbia University
Principal Investigator: Michael Parides, PhD Mount Sinai School of Medicine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01471795     History of Changes
Other Study ID Numbers: 08-1093 HP, 5P50HL077096
Study First Received: November 7, 2011
Last Updated: November 15, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Heart Failure
Prosthesis-Related Infections
Cardiovascular Diseases
Heart Diseases
Infection
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on October 23, 2014