Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

The Epidemiology of Ventricular Assist Device-Related Infections

15 de novembro de 2011 atualizado por: Icahn School of Medicine at Mount Sinai

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.

Visão geral do estudo

Status

Concluído

Condições

Insuficiência Cardíaca Congestiva

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

150

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Estados Unidos
- Alabama
  - Birmingham, Alabama, Estados Unidos, 35294
    - University of Alabama at Birmingham
- California
  - San Diego, California, Estados Unidos, 92123
    - Sharp Memorial Hospital
- Illinois
  - Oak Lawn, Illinois, Estados Unidos, 60453
    - Advocate Christ Medical Center
- Kentucky
  - Louisville, Kentucky, Estados Unidos, 40202
    - Jewish Hospital
- Michigan
  - Ann Arbor, Michigan, Estados Unidos, 48109
    - University of Michigan
- Minnesota
  - Minneapolis, Minnesota, Estados Unidos, 55455
    - University of Minnesota
- New York
  - Bronx, New York, Estados Unidos, 10467
    - Montefiore Medical Center
  - New York, New York, Estados Unidos, 10032
    - Columbia Presbyterian Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, Estados Unidos, 19104
    - Hospital of the University of Pennsylvania
- Utah
  - Salt Lake City, Utah, Estados Unidos, 84143
    - LDS Hospital
- Washington
  - Spokane, Washington, Estados Unidos, 99204
    - Sacred Heart Medical Center
- Wisconsin
  - Madison, Wisconsin, Estados Unidos, 53792
    - University of Wisconsin Hospital
  - Milwaukee, Wisconsin, Estados Unidos, 53215
    - St. Luke's Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Patients with end-stage heart failure who demonstrate the need for intermediate or long-term support with a VAD.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
The incidence of suspected infections, characterized by infecting organism and location. Prazo: 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.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Collect and quantify culture results for suspected infections and the secondary manifestations of infection Prazo: 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.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Develop Guidelines to properly diagnose VAD infections Prazo: 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.	Up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Costs (direct) Prazo: 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.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.
Adverse Events Prazo: 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.	Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Icahn School of Medicine at Mount Sinai

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)

Investigadores

Investigador principal: Michael Parides, PhD, Icahn School of Medicine at Mount Sinai
Diretor de estudo: Patrice Desvigne-Nickens, National Heart, Lung, and Blood Institute (NHLBI)
Cadeira de estudo: Yoshifumi Naka, MD, Columbia University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2006

Conclusão Primária (Real)

1 de janeiro de 2009

Conclusão do estudo (Real)