None listed
Conditions
Brief summary
The hypothesis to be tested by this study is that the improved clearance of middle molecules (thought to be important uremic toxins) by the new FX 80 membrane would lead to less oxidative stress and inflammation when compared to dialysis using a standard hig-flux membrane.
Interventions
Comparison of conventional high-flux dialysis (HF80 polysulfone membrane) with helixone high-flux dialysis (FX series polysulfone membrane). The FX series membrane has a higher molecular flux enabling greater clearance of middle molecules compared to the standard high flux membranes. All participants will maintain their standard dialysis regime (duration of dialysis per session, sessions per week and blood flow speed). The only difference between groups is the dialysis membrane used for the 12 m
Comparison of conventional high-flux dialysis (HF80 polysulfone membrane) with helixone high-flux dialysis (FX series polysulfone membrane). The FX series membrane has a higher molecular flux enabling greater clearance of middle molecules compared to the standard high flux membranes. All participants will maintain their standard dialysis regime (duration of dialysis per session, sessions per week and blood flow speed). The only difference between groups is the dialysis membrane used for the 12 month period
Sponsors
Fresenius Medical Care Southeast Asia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
stable haemodialysis patients aged from 18 to 75 years; using established arterio-venous fistulae or fistulae constructed from synthetic grafts; and who had been established on haemodialysis for at least 3 months.
Exclusion criteria
an inability to give informed consent; unlikely to remain on dialysis for at least 9 months (either due to impending demise or transplantation); prior demonstrated allergy to polysulfone membranes; dialysis via a central venous access catheter; any evidence of an ongoing inflammatory response including infection, auto-immune disorders, vasculitis, treatment with any immunosuppressive agents or the presence of any malignancy.
Outcome results
None listed