此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

The Epidemiology of Ventricular Assist Device-Related Infections

2011年11月15日更新者：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.

研究概览

地位

完全的

条件

充血性心力衰竭

详细说明

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.

研究类型

观察性的

注册 (实际的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

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

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
The incidence of suspected infections, characterized by infecting organism and location. 大体时间：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.

次要结果测量

结果测量	措施说明	大体时间
Collect and quantify culture results for suspected infections and the secondary manifestations of infection 大体时间：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 大体时间：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) 大体时间：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 大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Icahn School of Medicine at Mount Sinai

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

首席研究员：Michael Parides, PhD、Icahn School of Medicine at Mount Sinai
研究主任：Patrice Desvigne-Nickens、National Heart, Lung, and Blood Institute (NHLBI)
学习椅：Yoshifumi Naka, MD、Columbia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年1月1日

初级完成 (实际的)

2009年1月1日

研究完成 (实际的)

2009年1月1日

研究注册日期

首次提交

2011年11月7日

首先提交符合 QC 标准的

2011年11月15日

首次发布 (估计)

2011年11月16日

研究记录更新

最后更新发布 (估计)