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临床试验/NCT00714662
NCT00714662Unknown3 期

Effects of Different Frequencies of High-Flux Membranes on Blood Pressure, Fluid Balance, and Indices of Nutrition, Inflammation, and Dialysis Adequacy in Chronic Hemodialysis Patients - Comparisons Between Thrice vs Once Weekly

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
3 期
入组人数
80
试验地点
2
主要终点
blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy

研究概览

简要总结

To investigate the influence of different dialysis frequencies on the outcome of end-stage renal disease patients undergoing chronic hemodialysis therapy.

详细描述

This study will be conducted in the HD center at NTUH. Patients undergoing chronic HD for at least 6 months will be evaluated for eligibility. Patients with previous adverse reactions to FX series dialyzer will not be included in this study. Detailed demographic physical characteristics of the participants will be recorded, including age, gender, underlying diseases, blood pressure, intradialytic complications, as well as indices of nutrition, inflammation, and dialysis adequacy. Eligible patients will first undergo a 4-week run-in HD with conventional-flux dialyzer twice weekly plus high-flux dialyzer once weekly (i.e., basic formula), followed by random allocation into two separate groups. Patients in group A will continue HD with the basic formula, while those in group B will receive HD using high-flux membranes thrice weekly. Three months later, all participants will be put back on HD with basic formula for 1 month (wash-out period). Group A patients will then be switched to receive HD with high-flux membranes thrice weekly, and group B patients will be changed to undergo HD with basic formula for another 3 months. Laboratory tests will include monthly biochemistry and hemogram, plus blood and urine specimens taken on 4 occasions before and during the study (baseline, end of the first 3 months, end of wash-out, and end of the second 3 months) to investigate selective markers and indices for nutrition, inflammation, and dialysis adequacy.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ESRD patients under regular thrice weekly HD for more than 3 months in NTUH HD center.
  • Age: 18~80 years old.
  • Blood flow during dialysis ≧ 250ml/min

排除标准

  • Previous allergy to heparin or FX series dialyzer (FX-60, FX-80, FX-100)
  • Pre-dialysis systolic blood pressure ≦ 100mmHg (2week prior to enrollment)
  • Bacteremia, myocardial infarction or stroke in previous 3 months.
  • Known diagnosis with dialysis related amyloidosis

结局指标

主要结局

blood pressure, fluid balance, and indices of nutrition, inflammation, and dialysis adequacy

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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