Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Post-dilution on-line hemodiafiltration, 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.

Official Title
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Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Procedure: post-dilution on-line hemodiafiltration
* Procedure: high flux hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older than 18 years 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 be scheduled for living donor renal transplantation 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Post-dilution on-line hemodiafiltration<br>Post-dilution on-line hemodiafiltration | Procedure: post-dilution on-line hemodiafiltration<br>* post-dilution on-line hemodiafiltration, 3 times a week 4 hours<br>|
| Other: High-flux hemodialysis<br>High-flux hemodialysis | Procedure: high flux hemodialysis<br>* High-flux hemodialysis, 3 times a week 4 hours<br>* Other names: High-flux hemodialysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization. |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular mortality |  | two years | 
| hospitalization rate |  | two years | 
| intradialytic complications including hypotension and cramp |  | two years | 
| health-related quality of life, depression burden, cognitive function |  | two years | 
| required medications |  | two years | 
| changes in blood pressure, left ventricular geometry, arterial stiffness, post-dialysis body weight, upper mid-arm circumference, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin |  | two years | 
| postdialysis total body water determined by bioimpedance analysis |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-stage renal disease, hemodialysis, cardiovascular morbidity and mortality, high flux dialyser, on-line hemodiafiltration, arterial stiffness, inflammation, life quality, left ventricular hypertrophy