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Ultrapure Water System for Hemodialysis Therapy

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ClinicalTrials.gov Identifier: NCT01400126
Recruitment Status : Unknown
Verified November 2010 by Tel Aviv Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2011
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Tel Aviv Medical Center

July 21, 2011
July 22, 2011
July 22, 2011
August 2011
August 2012   (Final data collection date for primary outcome measure)
CRP [ Time Frame: 13 months ]
Same as current
No Changes Posted
blood pressure [ Time Frame: 13 months ]
Same as current
Not Provided
Not Provided
 
Ultrapure Water System for Hemodialysis Therapy
The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Chronic hemodialysis patients
  • The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for
  • Hemodialysis.
  • The Rate of Adverse Events Such as Hypotension During Hemodialysis Therapy With Ultra Pure Water
  • System as Compared to Conventional Water System.
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
Same as current
January 2013
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. chronic hemodialysis therapy thrice weekly > 3 months of therapy
  2. Signed an informed consent -

Exclusion Criteria:

  1. Enrolled to other study
  2. Ongoing infection -
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01400126
01
No
Not Provided
Not Provided
Prof. Doron Schwartz, TelAvivMC
Tel Aviv Medical Center
Not Provided
Not Provided
Tel Aviv Medical Center
November 2010