- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400126
Ultrapure Water System for Hemodialysis Therapy
July 21, 2011 updated by: Tel Aviv Medical Center
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.
Study Overview
Status
Unknown
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 Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Doron Schwartz, MD
- Email: dorons@tasmc.health.gov.il
Study Contact Backup
- Name: Gil Chernin, MD
- Email: gilc@tasmc.health.gov.il
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chronic hemodialysis patients
Description
Inclusion Criteria:
- chronic hemodialysis therapy thrice weekly > 3 months of therapy
- Signed an informed consent -
Exclusion Criteria:
- Enrolled to other study
- Ongoing infection -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CRP
Time Frame: 13 months
|
13 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure
Time Frame: 13 months
|
13 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
August 1, 2012
Study Completion (Anticipated)
January 1, 2013
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Estimate)
July 22, 2011
Last Update Submitted That Met QC Criteria
July 21, 2011
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01 (Miami VAHS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for
-
Bispebjerg HospitalCompletedInvestigate the Potential Network Limitations | Validate the Technology for Later Clinical Use | Evaluate System Integration of EndoAlphaDenmark
-
International Centre for Diarrhoeal Disease Research...University of California, Berkeley; University of Maryland; Harvard UniversityCompletedDevelop a New Group Version of the Becker-DeGroot-Marsckek (BDM) Auction to Measure Willingness to Pay of Compound Members for Shared Hardware. | Develop a New Survey Instrument to Measure Behavioural Determinants of Hand Washing and Water Treatment Like Disgust and Shame or Social... and other conditionsBangladesh
-
University of IowaCompletedThe Focus of the Study is to Monitor MRI Signal Changes and Inflammatory Biomarkers With Use of Aspirin in Patients With Unruptured Cerebral AneurysmUnited States
-
Novartis PharmaceuticalsWithdrawnPatients With Migraine Equal of /More Than 3 and Equal of/ Less Than 12 Migraine Attacks/4 Weeks for Each of the Last 6 Months Preceding the Screening
-
Chang Gung Memorial HospitalRecruitingThe Association of Postoperative Cognitive Dysfunction With Glymphatic Function and Neuroinflammation | The Association of Postoperative Cognitive Dysfunction With CSF Metabolomic ChangeTaiwan
-
Per PfeifferCompletedFirst-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus orDenmark
-
Johannes Gutenberg University MainzUnknownFocus of the Study is to Evaluate a New Developed Deep-learning Computer-aided Detection System in Combination With LCI for Colorectal Polyp DetectionGermany
-
Assiut UniversityCompletedUS-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge NeedleEgypt
-
University Hospital Center of MartiniqueClinique Antilles-Guyane; Fondation de FranceCompleted1- Women | 2- HIV Infection | 3- Followed in West Indies and French Guiana for His Infection | 4- Acceptance of the Use of Nadis® Medical FilesMartinique
-
Nan ShenNovartisNot yet recruitingCharacterize the Molecular Profile of Lupus Nephritis(LN) Patients to Understand Themechanism(s)Contributing to Patient Responsiveness to Soc | Integrated Analysis of LN Patient Molecular Profiling and Clinical Annotations to Understand LNdisease Heterogeneity for Disease Endotype | Validate the Association of the Candidate Biomarker Panel Proposed in Table 3-1 With LN Diseasemonitoring