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NCT05777148 Clinical Trial

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

End Stage Renal Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05777148
Other study ID # 3619
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 4, 2022
Est. completion date June 30, 2023

Study information
Verified date March 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 22
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• super high-flux hemodialysis
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)
• postdilution online hemodiafiltration
hemodialysis by post dilution online HDF technique for 24 week then crossover to super high-flux HD (wash out period 4 weeks)

Locations
Country Name City State
Thailand ramathibodi hospital, faculty of medicine, Ramathibodi hospital Phaya Thai Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 serum beta 2 microglobulin Measure mid-week prehemodialysis serum beta2 micro globulin At first week, 8th week, 16th week and 24th week
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