End-stage Renal Disease
Conditions
Keywords
beta 2-Microglobulin, Hemodiafiltration, convective volume
Brief summary
Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment. This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.
Interventions
PROCEDUREHigh Dose Online HDF
Convection volume; 33-43 L/treatment (140-180 mL/min)
PROCEDUREStandard Dose Online HDF
convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
Sponsors
Boryung Pharmaceutical Co., Ltd
Korean Hemodialysis Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients on thrice-weekly standard hemodialysis for \> 3 months * Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min) * Patients willing to provide written informed consent.
Exclusion criteria
* Patients with active infectious or uncontrolled inflammatory disorders * Patients with any uncontrolled malignant disease * Patients with recent major cardiovascular disease during the last 6 months * Patients who are likely to receive kidney transplant within the following 1 year * Patients whose life expectancy \< 12 months * Patients considered by investigator to have difficulty in participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in the serum concentration of β2 microglobulin | between baseline and 24 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Adequacy | 24 weeks | Kt/V by the single pool variable volume formula. |
| Inflammatory markers | 24 weeks | C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α. |
| Nutritional status | 24 weeks | normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA) |
| Intradialytic hypotension | 24 weeks | Number of episode of symptomatic hypotension |
| Quality of Life | baseline and 24 weeks after treatment | SF-36-K (Korean version) |
Countries
South Korea
Contacts
Primary ContactSung Gyun Kim, MD
Backup ContactSoo Jin Kim, MD
Outcome results
None listed