The Epidemiology of Ventricular Assist Device-Related Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- The incidence of suspected infections, characterized by infecting organism and location.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
The incidence of suspected infections, characterized by infecting organism and location.
时间窗: 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.
次要结局
- Collect and quantify culture results for suspected infections and the secondary manifestations of infection(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(Up to one year following VAD implantation, time of death or transplantation, whichever comes first.)
- Costs (direct)(Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.)
- Adverse Events(Duration of the study, up to one year following VAD implantation, time of death or transplantation, whichever comes first.)