The Epidemiology of Ventricular Assist Device-Related Infections

Congestive Heart Failure Clinical Trial

Official title:

The Epidemiology of Ventricular Assist Device-Related Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471795
• Other study ID #: 08-1093 HP
• Secondary ID: 5P50HL077096
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: November 15, 2011
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2011
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Prosthesis-Related Infections

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Jewish Hospital	Louisville	Kentucky
United States	University of Wisconsin Hospital	Madison	Wisconsin
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	LDS Hospital	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	Sacred Heart Medical Center	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of suspected infections, characterized by infecting organism and location.	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.	No
Secondary	Collect and quantify culture results for suspected infections and the secondary manifestations of infection	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.	No
Secondary	Develop Guidelines to properly diagnose VAD infections	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.	No
Secondary	Costs (direct)	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.	No
Secondary	Adverse Events	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.	No