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
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2022
CompletedFirst Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMarch 21, 2023
March 1, 2023
1.2 years
March 8, 2023
March 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
serum beta 2 microglobulin
At first week, 8th week, 16th week and 24th week
Study Arms (2)
postdilution online hemodiafiltration
EXPERIMENTALhemodialysis by using post dilution online HDF technique
super high-flux hemodialysis
EXPERIMENTALhemodialysis by using super high-flux dialyzer
Interventions
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)
hemodialysis by post dilution online HDF technique for 24 week then crossover to super high-flux HD (wash out period 4 weeks)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- contraindicated to anticoagulant
- active malignancy
- advanced liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ramathibodi hospital, faculty of medicine, Ramathibodi hospital
Phaya Thai, Bangkok, 10400, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 21, 2023
Study Start
April 4, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
March 21, 2023
Record last verified: 2023-03