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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic hemodialysis patients

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CRP	13 months

Secondary Outcome Measures

Outcome Measure	Time Frame
blood pressure	13 months

Collaborators and Investigators

• Sponsor: Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Ultrapure water,hemodialysis, CRP, blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 01 (Leona M. and Harry B. Helmsley Charitable Trust)