Ultrapure Water System for Hemodialysis Therapy

NCT ID: NCT01400126

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-01-31

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.

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.

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.

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv Medical Center

OTHER

Sponsor Role: lead

Responsible Party

TelAvivMC

Central Contacts

Doron Schwartz, MD

Role: CONTACT

dorons@tasmc.health.gov.il

Gil Chernin, MD

Role: CONTACT

gilc@tasmc.health.gov.il

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id