Ultrapure Water System for Hemodialysis Therapy
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Purpose
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.
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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 Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial |
- CRP [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- blood pressure [ Time Frame: 13 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Chronic hemodialysis patients
Inclusion Criteria:
- chronic hemodialysis therapy thrice weekly > 3 months of therapy
- Signed an informed consent -
Exclusion Criteria:
- Enrolled to other study
- Ongoing infection -
Contacts and Locations| Contact: Doron Schwartz, MD | dorons@tasmc.health.gov.il | |
| Contact: Gil Chernin, MD | gilc@tasmc.health.gov.il |
More Information
No publications provided
| Responsible Party: | Prof. Doron Schwartz, TelAvivMC |
| ClinicalTrials.gov Identifier: | NCT01400126 History of Changes |
| Other Study ID Numbers: | 01 |
| Study First Received: | July 21, 2011 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Israel: Isreali Ministary of Health |
Keywords provided by Tel Aviv Medical Center:
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Ultrapure water,hemodialysis, CRP, blood pressure |
Additional relevant MeSH terms:
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Hypotension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013