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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months
Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)
Manchester NHS Foundation Trust
Manchester, Lancashire, United Kingdom
Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers)
Change in vascular endothelial marker score (derived from multiple biomarkers)
Time frame: 6 months
Change in pulse wave velocity
Change in pulse wave velocity as measured by non-invasive pulse wave analysis device
Time frame: 6 months
Change in pre-dialysis serum albumin
Change in pre-dialysis serum albumin
Time frame: 3 & 6 months
Change in pre-dialysis CRP
Change in pre-dialysis CRP
Time frame: 3 & 6 months
Change in components of pre-dialysis "middle molecule" panel
Change in components of pre-dialysis "middle molecule" panel (this includes beta 2 microglobulin, serum free light chains, leptin, beta trace protein and prolactin)
Time frame: 3 & 6 months
Change in components of cytokine panel
Change in components of cytokine panel (including IL-6, TNFa, ICAM \& VEGF)
Time frame: 3 & 6 months
Change in numbers blood pressure medications
Change in numbers blood pressure medications
Time frame: 6 months
Change in number of phosphate binder medications
Change in number of phosphate binder medications
Time frame: 6 months
Change in Advanced Glycation End Products (AGE)
Change in Advanced Glycation End Products (AGE)
Time frame: 6 months
Change in inter-dialytic urine volume
Change in inter-dialytic urine volume
Time frame: 6 months
Change in IPOS-Renal (Integrated Palliative Care Outcome Score)
Change in IPOS-Renal (Integrated Palliative Care Outcome Score)
Time frame: 3 & 6 months
Change in self-sported dialysis recovery time
Change in self-sported dialysis recovery time
Time frame: 3 & 6 months
Change in Chalder fatigue scale
Change in Chalder fatigue scale (score range 0 to 33, high score indicating high levels of fatigue)
Time frame: 3 & 6 months
Hospitalisation episodes
Number of hospitalisation episodes during 6 months study period
Time frame: 6 months
All-cause mortality
All-cause mortality
Time frame: 6 months
Cardiovascular mortality
Cardiovascular mortality
Time frame: 6 months
Change in augmentation pressure (AP)
Change in segmentation pressure as measured by non-invasive pulse wave analysis device
Time frame: 6 months
Change in heart-rate adjusted augmentation index (AI)
Change in heart-rate adjusted augmentation index (AI) as measured by non-invasive pulse wave analysis device
Time frame: 6 months
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