Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis
NCT ID: NCT00411177
Last Updated: 2013-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
782 participants
INTERVENTIONAL
2007-01-31
2010-03-31
Brief Summary
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The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.
Detailed Description
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Seven hundred and eighty HD patients will be taken into the study. The study will last for two years with an intermediate analysis at the first year. The patients will be randomly placed in two groups:
1. Post-dilution on-line hemodiafiltration,
2. High-flux hemodialysis.
In both groups, FX series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF. Substitution volume will be above 15 liters in hemodiafiltration sessions.
Echocardiography for determination of left ventricular geometry, pulse wave velocity analysis to assess arterial stiffness, evaluation of nutritional and inflammatory state, assessment of life quality, depression and cost analysis will be performed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Post-dilution on-line hemodiafiltration
Post-dilution on-line hemodiafiltration
post-dilution on-line hemodiafiltration
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
High-flux hemodialysis
High-flux hemodialysis
high flux hemodialysis
High-flux hemodialysis, 3 times a week 4 hours
Interventions
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post-dilution on-line hemodiafiltration
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
high flux hemodialysis
High-flux hemodialysis, 3 times a week 4 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
* willingness to participate in the study with a written informed consent
Exclusion Criteria
* To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
* Pregnancy or lactating
* Current requirement for HD more than three times per week due to medical comorbidity
* GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
* Use of temporary catheter
* Insufficient vascular access (blood flow rate lower than 250 ml/min)
* Mental incompetence
18 Years
ALL
No
Sponsors
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Fresenius Medical Care North America
INDUSTRY
Ercan OK
OTHER
Responsible Party
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Ercan OK
professor
Principal Investigators
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Ercan Ok, MD
Role: PRINCIPAL_INVESTIGATOR
Ege University
Locations
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Ege University School of Medicine
Bornova, İzmir, Turkey (Türkiye)
FMC Clinics Turkey
Adana, , Turkey (Türkiye)
Countries
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Other Identifiers
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Ege0683
Identifier Type: -
Identifier Source: org_study_id