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Sponsors and Collaborators: |
Ege University Fresenius Medical Care North America |
---|---|
Information provided by: | Ege University |
ClinicalTrials.gov Identifier: | NCT00411177 |
This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. 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.
Condition | Intervention | Phase |
---|---|---|
End-Stage Renal Disease Hemodialysis |
Procedure: on-line hemodiafiltration Procedure: high flux hemodialysis |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Post-Dilution on-Line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY) |
Estimated Enrollment: | 780 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Post-dilution on-line hemodiafiltration
|
Procedure: on-line hemodiafiltration
on-line hemodiafiltration 3 times a week 4 hours
|
2
High-flux hemodialysis
|
Procedure: high flux hemodialysis
high flux hemodialysis 3 times a week 4 hours
|
The proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications.
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Turkey | |
FMC Clinics Turkey | |
Adana, Turkey, 01000 | |
Turkey, Izmir | |
Ege University School of Medicine | |
Bornova, Izmir, Turkey, 35100 |
Principal Investigator: | Ercan Ok, MD | Ege University |
Responsible Party: | Fresenius Medical Care ( Fresenius Medical Care ) |
Study ID Numbers: | Ege0683 |
Study First Received: | December 12, 2006 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00411177 History of Changes |
Health Authority: | Turkey: Ministry of Health |
end-stage renal disease hemodialysis cardiovascular morbidity and mortality high flux dialyser on-line hemodiafiltration |
arterial stiffness inflammation life quality left ventricular hypertrophy |
Hypertrophy, Left Ventricular Renal Insufficiency Hypertrophy Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Quality of Life Kidney Diseases Kidney Failure Inflammation |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |