The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System forNCT01400126
Ultrapure Water System for Hemodialysis Therapy
An observational study of The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for and Hemodialysis., run by Tel Aviv Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic hemodialysis patients
Who may be able to join
- chronic hemodialysis therapy thrice weekly > 3 months of therapy
- Signed an informed consent -
Who cannot join
- Enrolled to other study
- Ongoing infection -
Trial locations and contacts
No sites are listed yet.
Doron Schwartz, MD contact
Gil Chernin, MD contact
About this study
Official title: The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial
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.
Read the 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.
- Keywords
- Ultrapure water,hemodialysis, CRP, blood pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP
Measured: 13 months
Secondary outcomes (1)
blood pressure
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System forStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400126
- Sponsor's protocol ID
- 01
- Status last verified
- Nov 2010
- First submitted
- 21 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial
- ClinicalTrials.gov ID
- NCT01400126
- Acronym / sponsor ID
- 01
- 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.
- Keywords
- Ultrapure water,hemodialysis, CRP, blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel Aviv Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hemodialysis patients
Key inclusion criteria (2 listed)
- chronic hemodialysis therapy thrice weekly > 3 months of therapy
- Signed an informed consent -
Key exclusion criteria (2 listed)
- Enrolled to other study
- Ongoing infection -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CRP
Time frame: 13 months
1 secondary outcome
blood pressure
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doron Schwartz, MD contact
Gil Chernin, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for and Hemodialysis., run by Tel Aviv Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doron Schwartz, MD (dorons@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.