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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Hemodialysis.
  • Hypotension
  • System as Compared to Conventional Water System.
  • The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for
  • The Rate of Adverse Events Such as Hypotension During Hemodialysis Therapy With Ultra Pure Water

NCT number NCT01400126
Study type Observational
Source Tel Aviv Medical Center
Contact Doron Schwartz, MD
Email dorons@tasmc.health.gov.il
Status Not yet recruiting
Phase N/A
Start date August 2011
Completion date January 2013