Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 436
- 主要终点
- prevalence of HEV infection
研究概览
简要总结
Primary Purpose:
- Evaluate the prevalence and incidence of HEV infection in MHD patients.
- Compare differences of the prevalence and incidence between the MHD patients and the control. .
Secondary purpose:
Analyze risk factors of HEV infection.
详细描述
This is an Epidemiological study manufactured by Xiamen University. The primary purpose of this study is to evaluate the prevalence and incidence of HEV infection in MHD patients and to compare differences between the MHD patients and the control. The secondary purpose of this study is to analyze risk factors of the infection of HEV. There are two phases in this study. The first phase is a cross-sectional study. Approximately 200 MHD patients will be enrolled in MHD patient group, followed by control group's enrollment according to the age and gender of the MHD patient group. Blood samples and questionnaire were got at this time. Secondly, 100 enrolled volunteers in each group who is negative for HEV-IgM、HEV-IgG、HEV RNA will be introduced into the cohort study. The MHD patient group will been taken blood samples at an interval of 3 month until the 12th month after the first phase, however, the control group only need one blood sample at 12th month.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maintenance hemodialysis patients and healthy people as control
- •Can understand the study progress, willing to sign the informed consent and participate the study
排除标准
- •Has received HEV vaccines
结局指标
主要结局
prevalence of HEV infection
时间窗: up to 1 year after enrollment
number and rate of participants with abnormal laboratory values in the MHD patients and the control;
new-infection rate of HEV infection
时间窗: up to 1 year after enrollment
number and rate of the participants who's baseline laboratory value is normal and change to abnormal during the follow-up in the MHD patients and the control
次要结局
- risk factors of HEV infection(up to 1 year after enrollment)
研究者
Jun Zhang
vice-president of School of public health
Xiamen University