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Ultrapure Water System for Hemodialysis Therapy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01400126
Enrollment
150
Registered
2011-07-22
Start date
2011-08-31
Completion date
2013-01-31
Last updated
2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis., 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

Keywords

Ultrapure water,hemodialysis, CRP, blood pressure

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.

Interventions

None listed

Sponsors

Tel Aviv Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frame
CRP13 months

Secondary

MeasureTime frame
blood pressure13 months

Contacts

Primary ContactDoron Schwartz, MD
dorons@tasmc.health.gov.il
Backup ContactGil Chernin, MD
gilc@tasmc.health.gov.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026