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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.
Other secondary outcomes that the researcher wants to study are
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predilution online hemodiafiltration | Experimental | The dialysis mode will be set as predilution online hemodiafiltration for 8 weeks. |
|
| Hemodialysis | Active Comparator | The dialysis mode will be set as conventional hemodialysis for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISIO21HX | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Protein bound uremic toxin reduction ratio (percent) | 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent) | 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. | 8 weeks |
| Serum albumin and dialysate albumin loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rossanun Shoosanglertwijit | Chulalongkorn University | Principal Investigator |
| Khajohn Tiranathanagul | Chulalongkorn University | Principal Investigator |
| Pajaree Chariyavilaskul | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Chulalongkorn university | Pathum Wan | Bangkok | 10330 | Thailand |
Share only the results of the study.
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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.
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|
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. |
| 8 weeks |
| Quality of life assessment in each group | Quality of life was assessed by the KDQOL36 questionnaire in each intervention | 8 weeks |
| ID | Term |
|---|---|
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D007239 | Infections |
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