NCT01578421已完成不适用
Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser
Kantonsspital Aarau2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Clearance and removal rate of phosphate, beta2 microglobulin and leptin
研究概览
简要总结
The purpose of the study is to compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •hemodialysis patients 18 years and older
- •treated by post dilution on-line Hemodiafiltration (HDF) for at least one month
- •who reached a dialysis dose (Kt/V) of at least 1.2 at each of the last two monthly checks
- •who are on a stable anticoagulation and anemia management
- •whose hemoglobin is between 10.5 and 13.0 g/dl
- •who are clinically stable based on judgment of nephrologist
- •who are on a regular thrice weekly HDF schedule, e.g. Monday-Wednesday-Friday or Tuesday-Thursday-Saturday,
- •who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min)
- •who are able to understand the nature and requirements of the clinical investigation and who have given written informed consent
排除标准
- •with active Hepatitis B, Hepatitis C or HIV infection
- •who are severely malnourished as judged by the principal investigator
- •who are known or suspected to have allergy to the trial products or related products
- •with a central venous catheter based vascular access
- •who are abusing non-legal drugs or alcohol
- •who have currently active malignant disease
- •who are female of child-bearing age without effective measures of contraception, pregnant or breastfeeding
- •who participate simultaneously in another clinical investigation
- •who have participated in othe clinical investigations during the last month
- •who are uncooperative
结局指标
主要结局
Clearance and removal rate of phosphate, beta2 microglobulin and leptin
时间窗: 4 hour
during a 4 hour online hemodiafiltration session
次要结局
未报告次要终点
研究者
Andreas Bock
Prof. Andreas Bock, Chefarzt Nephrologie
Kantonsspital Aarau
研究点 (2)
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