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The Epidemiology of Ventricular Assist Device-Related Infections

NCT ID: NCT01471795

Last Updated: 2011-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrice Desvigne-Nickens

Role: STUDY_DIRECTOR

National Heart, Lung, and Blood Institute (NHLBI)

Yoshifumi Naka, MD

Role: STUDY_CHAIR

Columbia University

Michael Parides, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status

Jewish Hospital

Louisville, Kentucky, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Columbia Presbyterian Medical Center

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Sacred Heart Medical Center

Spokane, Washington, United States

Site Status

University of Wisconsin Hospital

Madison, Wisconsin, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23315371 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22457291 (View on PubMed)

Other Identifiers

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5P50HL077096

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-1093 HP

Identifier Type: -

Identifier Source: org_study_id