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Ultrapure Water System for Hemodialysis Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Tel Aviv Medical Center

Brief 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.

Condition or disease
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.

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial
Study Start Date : August 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. CRP [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 13 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic hemodialysis patients

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01400126

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Contact: Doron Schwartz, MD
Contact: Gil Chernin, MD

Sponsors and Collaborators
Tel Aviv Medical Center

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Responsible Party: Prof. Doron Schwartz, TelAvivMC Identifier: NCT01400126     History of Changes
Other Study ID Numbers: 01
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: November 2010
Keywords provided by Tel Aviv Medical Center:
Ultrapure water,hemodialysis, CRP, blood pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases