Effectiveness of High-volume Online Hemodiafiltration Compared to Standard Volume Online Hemodiafiltration. A Prospective, Multicenter, Randomized, Open-labelled Interventional Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End-stage Renal Disease
- Sponsor
- Korean Hemodialysis Study Group
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- changes in the serum concentration of β2 microglobulin
- Last Updated
- 12 years ago
Overview
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.
Investigators
Sung Gyun Kim
Professor
Korean Hemodialysis Study Group
Eligibility Criteria
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
Outcomes
Primary Outcomes
changes in the serum concentration of β2 microglobulin
Time Frame: between baseline and 24 weeks after treatment
Secondary Outcomes
- Inflammatory markers(24 weeks)
- Intradialytic hypotension(24 weeks)
- Quality of Life(baseline and 24 weeks after treatment)
- Dialysis Adequacy(24 weeks)
- Nutritional status(24 weeks)