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临床试验/NCT01400126
NCT01400126Unknown不适用

The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial

Tel Aviv Medical Center0 个研究点目标入组 150 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
主要终点
CRP

研究概览

简要总结

We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure water) in comparison with the use of conventional water which are used in most dialysis units worldwide. To the best of our knowledge prospective data in that field is sparse.

详细描述

In observational studies, the use of very pure dialysis solution has been suggested to reduce the plasma level of CRP, IL-6 ; to improve the response to anemia to erythropoietin therapy ; to promote better nutrition as evidenced by increase in plasma albumin value , estimated dry body weight, midarm muscle circumference and urea-nitrogen appearance rate; to reduce plasma level of β2-microglobulin and pentosidine ; to dely carpal tunnel syndrome ; to slow the loss of residual renal function; and to lower cardiovascular morbidity.The aim of this study is to prospectively evaluate the effect of dialysis performed with ultra-pure water (UPW)in comparison with dialysis with the use of conventional water system. Patients enrolled into this study will be evaluated at initial period of one month treated with conventional water system (-30 to 0 days). Then water system will be switched to ultra-pure water system with the use of filter added to the dialysis machine (Gambro). After switching to UPW system the patients will be followed for a period of one year (days 0-365). Primary end point will be change in CRP. Additional parameters: Blood pressure, adverse events during dialysis, hemoglobin levels and white-blood cell counts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic hemodialysis therapy thrice weekly > 3 months of therapy
  • Signed an informed consent -

排除标准

  • Enrolled to other study
  • Ongoing infection -

结局指标

主要结局

CRP

时间窗: 13 months

次要结局

  • blood pressure(13 months)

研究者

发起方
Tel Aviv Medical Center
申办方类型
Other

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