High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease

Study Overview
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Brief Summary
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This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self matching study, participants will receive high-flux hemodialysis compared to hemodiafiltration.

Detailed Description
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Hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water, is one of the most commonly replacement therapy. Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.

Official Title
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High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease

Conditions
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Chronic Kidney Failure

Intervention / Treatment
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* Other: High-flux hemodialysis
* Other: Hemodiafiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has end-stage renal disease. Subject has been on regular dialysis treatment for at least 6 months. Subject has autologous vascular access. Subject is offered thrice weekly hemodialysis. Subject is offered 4 hours duration hemodialysis. Exclusion Criteria: Infectious disease Poor echocardiographic window that was unsuitable for interpretation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flux hemodialysis<br>High-flux hemodialysis lasting for 4 hours | Other: High-flux hemodialysis<br>* High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.<br>|
| Active Comparator: Hemodiafiltration<br>Hemodiafiltration lasting for 4 hours | Other: Hemodiafiltration<br>* Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of moderate molecule substance | Clearance rate of b2-microglobulin for one dialysis. | 4 hours after dialysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | Left ventricular ejection fraction is calculated by dividing the volume of blood pumped from the left ventricle per beat, also known as stroke volume, by the end-diastolic volume. | 4 hours after dialysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, hemodiafiltration, end-stage renal disease