Ultrapure Water System for Hemodialysis Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tel Aviv Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel Aviv Medical Center
ClinicalTrials.gov Identifier:
NCT01400126
First received: July 21, 2011
Last updated: NA
Last verified: November 2010
History: No changes posted
  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.


Condition
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

Resource links provided by NLM:


Further study details as provided by Tel Aviv Medical Center:

Primary Outcome Measures:
  • CRP [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic hemodialysis patients

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400126

Contacts
Contact: Doron Schwartz, MD dorons@tasmc.health.gov.il
Contact: Gil Chernin, MD gilc@tasmc.health.gov.il

Sponsors and Collaborators
Tel Aviv Medical Center
  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:
Ultrapure water,hemodialysis, CRP, blood pressure

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014