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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Convection volume; 33-43 L/treatment (140-180 mL/min)
convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Shamyook Medical Center
Seoul, South Korea
Yonsei University Gangnam Severance Hospital
Seoul, South Korea
changes in the serum concentration of β2 microglobulin
Time frame: between baseline and 24 weeks after treatment
Dialysis Adequacy
Kt/V by the single pool variable volume formula.
Time frame: 24 weeks
Inflammatory markers
C-reactive protein (CRP), interleukin-6, tumor necrosis factor-α.
Time frame: 24 weeks
Nutritional status
normalized protein nitrogen appearance rate, serum albumin, serum protein, subjective global assessment (SGA)
Time frame: 24 weeks
Intradialytic hypotension
Number of episode of symptomatic hypotension
Time frame: 24 weeks
Quality of Life
SF-36-K (Korean version)
Time frame: baseline and 24 weeks after treatment
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