Uremic; Toxemia
Conditions
Keywords
Super High-flux dialyzers, Medium cut-off membrane, Protein bound uremic toxin, Indoxyl sulfate, Dialysate albumin loss, Albumin, Kappa free light chain, Lambda free light chain, Pre-dilution online HDF, Conventional hemodialysis
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
Interventions
DEVICEELISIO21HX
Super-high flux dialyzers (ELISIO21HX) will be used. The blood flow rate and dialysate flow rate will be set as 400 and 800 ml/min respectively for 4 hours of dialysis.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After a run-in period, the patients were randomly allocated to receive either 8-week of predilution hemodiafiltration using super-high flux, ELISIO-21HX, or hemodialysis using super-high flux as the control treatment. After a wash-out period of hemodiafiltration using high flux dialyzer, they were assigned to receive the other treatment for 8 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Chronic hemodialysis patients in King Chulalongkorn Memorial hospital * Residual renal function less than 100 ml/day
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Quality of life assessment in each group | 8 weeks | Quality of life was assessed by the KDQOL36 questionnaire in each intervention |
Countries
Thailand
Outcome results
None listed