A comparison of conventional high-flux versus a novel Helixone dialysis membrane on oxidative stress in stable haemodialysis patients.
Not Applicable
Completed
- Conditions
- HaemodialysisRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12610000427077
- Lead Sponsor
- Fresenius Medical Care Southeast Asia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effects of the dialyser membrane on markers of plasma protein and lipid oxidation, inflammatory markers including pro-inflammatory cytokines and cell adhesion molecules over a 12 month period. The primay outcome is a composite of the measures of oxidative stress listed below<br>Protein thiols are measured colorimetrically. Protein-bound dityrosine fluorescence and protein-bound lipofuscin-like fluorophores are measured fluorometrically. Protein carbonyls are measured colorimetrically. Plasma oxidised low density lipoproteins are measured by immunoassay. Protein peroixdes are measured enzymatically. Plasma C reactive protein is measured by high sensitivity immunoturbidimetric assay. Interleukin-6 (IL-6) and vascular cell adhesion molecule (VCAM) are measured by enzyme linked immunosorbent assays.[Baseline, 3 months and 12 months]
- Secondary Outcome Measures
Name Time Method il[Nil]