Clinical trial NCT01471795: The Epidemiology of Ventricular Assist Device-Related Infections
Official title: The Epidemiology of Ventricular Assist Device-Related Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-11-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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.

Primary outcomes:
measure: The incidence of suspected infections, characterized by infecting organism and location.
timeFrame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Secondary outcomes:
measure: Collect and quantify culture results for suspected infections and the secondary manifestations of infection
timeFrame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
measure: Develop Guidelines to properly diagnose VAD infections
timeFrame: Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
measure: Costs (direct)
timeFrame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
measure: Adverse Events
timeFrame: Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Patrice Desvigne-Nickens
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Yoshifumi Naka, MD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: Michael Parides, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gordon RJ, Weinberg AD, Pagani FD, Slaughter MS, Pappas PS, Naka Y, Goldstein DJ, Dembitsky WP, Giacalone JC, Ferrante J, Ascheim DD, Moskowitz AJ, Rose EA, Gelijns AC, Lowy FD; Ventricular Assist Device Infection Study Group. Prospective, multicenter study of ventricular assist device infections. Circulation. 2013 Feb 12;127(6):691-702. doi: 10.1161/CIRCULATIONAHA.112.128132. Epub 2013 Jan 11.
citation: Gordon RJ, Miragaia M, Weinberg AD, Lee CJ, Rolo J, Giacalone JC, Slaughter MS, Pappas P, Naka Y, Tector AJ, de Lencastre H, Lowy FD. Staphylococcus epidermidis colonization is highly clonal across US cardiac centers. J Infect Dis. 2012 May 1;205(9):1391-8. doi: 10.1093/infdis/jis218. Epub 2012 Mar 29.