Back to resultsComparison 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
Primary Purpose
End Stage Renal Disease
Status
Active
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
super high-flux hemodialysis
postdilution online hemodiafiltration
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring hemodiafiltration, super high-flux hemodialysis, advanced glycation end products
Eligibility Criteria
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
Sites / Locations
- ramathibodi hospital, faculty of medicine, Ramathibodi hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
postdilution online hemodiafiltration
super high-flux hemodialysis
Arm Description
hemodialysis by using post dilution online HDF technique
hemodialysis by using super high-flux dialyzer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
serum beta 2 microglobulin
Measure mid-week prehemodialysis serum beta2 micro globulin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05777148
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
hemodiafiltration, super high-flux hemodialysis, advanced glycation end products
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postdilution online hemodiafiltration
Arm Type
Experimental
Arm Description
hemodialysis by using post dilution online HDF technique
Arm Title
super high-flux hemodialysis
Arm Type
Experimental
Arm Description
hemodialysis by using super high-flux dialyzer
Intervention Type
Device
Intervention Name(s)
super high-flux hemodialysis
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
postdilution online hemodiafiltration
Intervention Description
hemodialysis by post dilution online HDF technique for 24 week then crossover to super high-flux HD (wash out period 4 weeks)
Primary Outcome Measure Information:
Title
skin autofluorescence for AGEs
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
serum beta 2 microglobulin
Description
Measure mid-week prehemodialysis serum beta2 micro globulin
Time Frame
At first week, 8th week, 16th week and 24th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ramathibodi hospital, faculty of medicine, Ramathibodi hospital
City
Phaya Thai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this 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
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