NCT01111266已完成不适用
Evaluation of Performance and Safety Profile of Xevonta High Flux Dialyzer With Special Focus on Determination of in Vivo Ultrafiltration Coefficient in Patients With CKD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- in vivo KUF
研究概览
简要总结
The purpose of this study is to determine the in-vivo ultrafiltration coefficient for different sizes of xevonta High-Flux dialyzers following FDA guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Written informed consent obtained from patient or parents/ guardian.
- •Subject age >= 18
- •Effective blood flow 350 ml/min and dialysate flow of 500 ml/min
- •On hemodialysis for a minimum of 3 months
- •Use of Cimino- or Gore-tex shunts
- •Routine dialysis-treatment for 240 min
- •Documented dialysis adequacy parameter that has been stable for past 3 months
- •Plan to dialyze at participating hemodialysis centre for at least 3-months duration.
- •Free from any currently known unusual clotting or access problems
- •Hepatitis B surface antigen (HbsAg) negative, documented within the past 90 days or Hepatitis B surface antibody (anti-HBs) positive.
- •Anti Hepatitis C Virus (Anti-HCV) negative, documented within the past 90 days
- •Anti Human Immunodeficiency Virus (Anti HIV) negative, documented within the past 90 days
- •Hematocrit (HCT) between 25 and 40% or haemoglobin (Hb) not less than 8 g/dL, as documented 14 days prior to the first treatment
排除标准
- •Patients who are unable to tolerate an effective blood flow of 350 ml/min
- •Patients using catheter for dialysis
- •Pregnant or nursing woman. Women of childbearing potential must agree to avoid pregnancy during the study period by use of hormonal contraception (implantable; patch; oral) and/ or double-barrier methods (any double combination of: IUD; condom with spermicidal gel; diaphragm; sponge; cervical cap)
- •Previous plan for extended absences from the participating hemodialysis centre
- •Expected to be transplanted (living related donor) within the maximum of 3 months for the study period
- •Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
结局指标
主要结局
in vivo KUF
时间窗: 6 weeks
The objective of this study is to to determine in vivo KUF for three different sizes (1.2; 1.8 and 2.3 m\^2) of xevonta High-Flux to compare obtained data with respective in vitro KUF data.
次要结局
- Determination of removal rates(6 weeks)
研究者
研究点 (2)
Loading locations...
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