Cardiovascular Diseases Clinical Trial
Official title:
A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF
The aim of this study is to evaluate haemodialysis treatment using a medium cut-off dialysis
membrane (Theranova) compared with on-line haemodiafiltration treatment with respect to
markers of endothelial health (plasma endothelial microvesicle levels, pro-inflammatory and
pro-coagulant markers).
This study will also compare the 2 treatment modalities with respect to several other outcome
measures including patient-reported outcome measures, haemodynamic parameters and advanced
glycation end-products.
To date, methods of improving outcomes for haemodialysis patients have focused on improving
small molecule clearance (urea); however, the benefits do not appear to be linear and
increasing Kt/V above 1.3 shows no benefit. Current dialysis therapies are unable to provide
effective clearance of larger "middle molecules" (between 20kDa and 60kDa) and retention of
these molecules may be linked to poor outcomes in haemodialysis patients.
Medium cut-off (MCO) dialysis membranes have been recently developed to address this area of
unmet need and provide an enhanced clearance of some larger middle molecules when compared
with high flux haemodialysis (HFHD) and even high volume haemodiafiltration (HDF). The
clinical benefit of this therapy is yet to be defined.
The aim of this study is to investigate the effect of HDx therapy (expanded haemodialysis
therapy through the use of a MCO haemodialysis membrane- Theranova) on vascular endothelial
and inflammatory biomarkers compared with high volume HDF therapy. Through the use of
endothelial microvesicles (EMV) as a marker of vascular endothelial health, which strongly
correlate with cardiovascular outcomes in end-stage real disease (ESRD) patients, this pilot
study will take the first steps into exploring whether HDx treatment provides clinical
benefits in addition to its simplicity of implementation. Additionally, other important
parameters, such as dialysis recovery time, patient-reported outcome measures and volume
management will also be explored and compared with high volume HDF.
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