A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online HDF Modalities
- Conditions
- Uremic; Toxemia
- Registration Number
- NCT06567483
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients.
The main questions aim to answer are the reduction ratio of protein bound uremic toxins
Participants will undergone the pre-dilution online hemodiafiltration and conventional hemodialysis for each 8 weeks followed by washout phase for 4 weeks.
- Detailed Description
Other secondary outcomes that the researcher wants to study are
1. The reduction ratio of Beta2microglobulin, kappa and lambda free light chain
2. Serum albumin and dialysate albumin loss
3. Quality of life, muscle mass and nutritional status of the patients
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Chronic hemodialysis patients in King Chulalongkorn Memorial hospital
- Residual renal function less than 100 ml/day
- Dialyzer allergy
- Malnutrition requiring intradialytic parenteral nutrition
- Cirrhosis child C or decompensated cirrhosis
- Active uncontrolled infection
- Active cardiovascular disease
- Advanced stage malignancy
- Predicted to be undergone living related kidney transplant within 1 year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Protein bound uremic toxin reduction ratio (percent) 8 weeks The reduction ratio of indoxyl sulfate will be calculated as percent by pre and post dialysis data. The measurement will take place in the pre-dialysis of the first and the last time of intervention
- Secondary Outcome Measures
Name Time Method Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent) 8 weeks The reduction ratio of the beta2 microglobulin, kappa and lambda free light chain and urea will be measure at the first and the last time of intervention by pre and post dialysis level.
Quality of life assessment in each group 8 weeks Quality of life was assessed by the KDQOL36 questionnaire in each intervention
Serum albumin and dialysate albumin loss 8 weeks Serum albumin will be followed at the midweek pre-dialysis at the first and 8th weeks of intervention.
Dialysate albumin will also be assessed at the 1st and the 8th weeks.
Trial Locations
- Locations (1)
Faculty of Medicine Chulalongkorn university
🇹🇭Pathum Wan, Bangkok, Thailand
Faculty of Medicine Chulalongkorn university🇹🇭Pathum Wan, Bangkok, Thailand