Ultrapure Water System for Hemodialysis Therapy

Hemodialysis. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01400126
• Other study ID #: 01
• Status: Not yet recruiting
• Phase: N/A
• First received: July 21, 2011
• Last updated: July 21, 2011
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: November 2010
• Source: Tel Aviv Medical Center
• Contact: Doron Schwartz, MD
• Email: dorons[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Isreali Ministary of Health
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP		13 months	No
Secondary	blood pressure		13 months	No