Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare efficacy in advanced glycation end products removal between Super high-flux Hemodialysis and high-volume post-dilution online hemodiafiltration. The main question it aims to answer are Efficacy : endothelial dysfunction biomarker (AGEs) in super high-flux hemodialysis compared to online HDF Safety profile : Dialysate albumin loss, Intradialytic complication Participants will be asked to randomized in 2 groups : Super high-flux HD or post dilution ol-HDF Researchers will compare SHF-HD and ol-HDF to see whether SHF-HD could remove AGEs better than ol-HDF

Official Title
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Comparison of Efficacy in Removal of Advanced Glycation End Products (AGEs) Between Super High-flux Hemodialysis and Postdilution Online Hemodiafiltration: A Single-center, Prospective, Open-label, Crossover Randomized Controlled Trial

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: super high-flux hemodialysis
* Device: postdilution online hemodiafiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic HD > 3 months Adequate small molecule uremic toxins removal Kt/v > 1.8 in HD 2 times/week Kt/v > 1.2 in HD 3 times/week BFR > 300 mL/min RKF < 100 ml/day Hemodynamically stable for > 2 weeks Exclusion Criteria: contraindicated to anticoagulant active malignancy advanced liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: postdilution online hemodiafiltration<br>hemodialysis by using post dilution online HDF technique | Device: postdilution online hemodiafiltration<br>* hemodialysis by post dilution online HDF technique for 24 week then crossover to super high-flux HD (wash out period 4 weeks)<br>|
| Experimental: super high-flux hemodialysis<br>hemodialysis by using super high-flux dialyzer | Device: super high-flux hemodialysis<br>* Super high-flux hemodialysis (SHF-HD) is hemodialysis using Super high-flux dialyzer for 24 week then crossover to post dilution online HDF (wash out period 4 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin autofluorescence for AGEs | SAF was measured by using a certified Autofluorescence Reader (AGE Reader, DiagnOptics, Groningen, The Netherlands). The AGEs reader uses an excitation light source between 300 and 420 nm to illuminate a skin surface that is about 1 cm2 in size and shielded from outside light. A spectrometer (AVS-USB2000, Avantes Inc., Eerbeek, The Netherlands) is used to measure the emission light from the skin in the 300- to 600-nm region using a 200-mm glass fiber. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum beta 2 microglobulin | Measure mid-week prehemodialysis serum beta2 micro globulin | At first week, 8th week, 16th week and 24th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodiafiltration, super high-flux hemodialysis, advanced glycation end products