NCT04122222已完成不适用
Immune Response to Influenza Vaccination in ESRD Patients Undergoing Hemodialysis vs. Hemodiafiltration
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- measurement antibody titers, determined by hemagglutination inhibition (HI) assay.
研究概览
简要总结
On-line hemodiafiltration (HDF) clears more azotaemic toxins compared to high-flux hemodialysis (HD). The response to vaccination is impaired in dialysis patients. We aimed to study the immune responses to influenza vaccine in dialysis patients treated by HDF vs. HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open label
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD patients aged 18 years or older, who had been treated for more than one month of either thrice weekly on-line hemodiafiltration (HDF) or conventional high flux hemodialysis (HD), with a session dialyzer urea clearance (Kt/V urea) of 1.2 and greater, with a convection volume target of 20 L/session for the HDF group
排除标准
- •Had received any vaccination within the previous four weeks, or influenza vaccination within six months
- •Patient who reported upper respiratory tract symptoms within three days prior to the study vaccination
- •A history of allergy to influenza vaccine or egg
- •Thrombocytopenia
- •In receipt of immunosuppressant medications, chemotherapy, or had immunodeficiency
研究组 & 干预措施
Hemodialysis
Active Comparator
ESRD patients treated by hemodialysis
干预措施: Influenza vaccine (Biological)
Hemodiafiltration
Active Comparator
ESRD patients treated by on-line hemodiafiltration
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
measurement antibody titers, determined by hemagglutination inhibition (HI) assay.
时间窗: 12 months
measurement antibody titers, determined by hemagglutination inhibition (HI) assay.
次要结局
- measurement T cell subpopulations, determined by flow cytometer AND cell proliferation assay after stimulated with influenza viruses.(12 months)
研究者
Arkom Nongnuch
Assist. Prof
Mahidol University
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