High Versus Standard Volume Hemodiafiltration in Asia

Study Overview
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Brief Summary
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Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment. This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.

Official Title
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Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Procedure: High Dose Online HDF
* Procedure: Standard Dose Online HDF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on thrice-weekly standard hemodialysis for > 3 months Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min) Patients willing to provide written informed consent. Exclusion Criteria: Patients with active infectious or uncontrolled inflammatory disorders Patients with any uncontrolled malignant disease Patients with recent major cardiovascular disease during the last 6 months Patients who are likely to receive kidney transplant within the following 1 year Patients whose life expectancy < 12 months Patients considered by investigator to have difficulty in participation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Standard Dose online HDF<br>Proposed target convection volume; 16.8-21.5 L/treatment (70-90 mL/min) | Procedure: Standard Dose Online HDF<br>* convection volume; 16.8-21.5 L/treatment (70-90 mL/min)<br>* Other names: Standard Volume online hemodiafiltration;|
| Experimental: High Dose online HDF<br>Proposed target convection volume; 33-43 L/treatment (140-180 mL/min). | Procedure: High Dose Online HDF<br>* Convection volume; 33-43 L/treatment (140-180 mL/min)<br>* Other names: High Volume online hemodiafiltration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the serum concentration of β2 microglobulin |  | between baseline and 24 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis Adequacy | Kt/V by the single pool variable volume formula. | 24 weeks | 
| Inflammatory markers | C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α. | 24 weeks | 
| Nutritional status | normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA) | 24 weeks | 
| Intradialytic hypotension | Number of episode of symptomatic hypotension | 24 weeks | 
| Quality of Life | SF-36-K (Korean version) | baseline and 24 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta 2-Microglobulin, Hemodiafiltration, convective volume