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

Not Applicable

Active, not recruiting

• Conditions: End Stage Renal Disease
• Interventions: Device: postdilution online hemodiafiltration; Device: super high-flux hemodialysis

• Registration Number: NCT05777148
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
postdilution online hemodiafiltration	postdilution online hemodiafiltration	hemodialysis by using post dilution online HDF technique
super high-flux hemodialysis	super high-flux hemodialysis	hemodialysis by using super high-flux dialyzer

Primary Outcome Measures

Name	Time	Method
skin autofluorescence for AGEs	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
serum beta 2 microglobulin	At first week, 8th week, 16th week and 24th week	Measure mid-week prehemodialysis serum beta2 micro globulin

Trial Locations

Locations (1)

ramathibodi hospital, faculty of medicine, Ramathibodi hospital; 🇹🇭 Phaya Thai, Bangkok, Thailand