Comparison of MCO HD on Markers of Vascular Health Compared With On-Line Haemodiafiltration
- Conditions
- Cardiovascular DiseasesEnd Stage Renal DiseaseInflammation
- Interventions
- Device: On-Line HaemodiafiltrationDevice: Medium Cut-Off Haemodialysis
- Registration Number
- NCT03510520
- Lead Sponsor
- Manchester University NHS Foundation Trust
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- Established on in-centre haemodiafiltration (HDF) for greater than 12 weeks with a minimum of 3 treatment sessions per week
- Ability to consent
- Planned live donor renal transplant within 6 months (with confirmed date)
- Planned switch in renal replacement modality (ie. to peritoneal dialysis or home haemodialysis)
- Clinician predicted prognosis < 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description On-Line Haemodiafiltration On-Line Haemodiafiltration Participant will remain on their usual on-line haemodiafiltration (HDF) treatment for the 6 month study duration (3 times per week treatment). Medium Cut-Off Haemodialysis (Theranova) Medium Cut-Off Haemodialysis Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment).
- Primary Outcome Measures
Name Time Method Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers) 6 months Change in vascular endothelial marker score (derived from multiple biomarkers)
- Secondary Outcome Measures
Name Time Method Change in pulse wave velocity 6 months Change in pulse wave velocity as measured by non-invasive pulse wave analysis device
Change in pre-dialysis serum albumin 3 & 6 months Change in pre-dialysis serum albumin
Change in inter-dialytic urine volume 6 months Change in inter-dialytic urine volume
Change in heart-rate adjusted augmentation index (AI) 6 months Change in heart-rate adjusted augmentation index (AI) as measured by non-invasive pulse wave analysis device
Change in components of pre-dialysis "middle molecule" panel 3 & 6 months Change in components of pre-dialysis "middle molecule" panel (this includes beta 2 microglobulin, serum free light chains, leptin, beta trace protein and prolactin)
Change in Chalder fatigue scale 3 & 6 months Change in Chalder fatigue scale (score range 0 to 33, high score indicating high levels of fatigue)
Change in number of phosphate binder medications 6 months Change in number of phosphate binder medications
Cardiovascular mortality 6 months Cardiovascular mortality
Change in augmentation pressure (AP) 6 months Change in segmentation pressure as measured by non-invasive pulse wave analysis device
Change in components of cytokine panel 3 & 6 months Change in components of cytokine panel (including IL-6, TNFa, ICAM \& VEGF)
Change in numbers blood pressure medications 6 months Change in numbers blood pressure medications
Change in IPOS-Renal (Integrated Palliative Care Outcome Score) 3 & 6 months Change in IPOS-Renal (Integrated Palliative Care Outcome Score)
Change in self-sported dialysis recovery time 3 & 6 months Change in self-sported dialysis recovery time
All-cause mortality 6 months All-cause mortality
Change in Advanced Glycation End Products (AGE) 6 months Change in Advanced Glycation End Products (AGE)
Hospitalisation episodes 6 months Number of hospitalisation episodes during 6 months study period
Change in pre-dialysis CRP 3 & 6 months Change in pre-dialysis CRP
Trial Locations
- Locations (1)
Manchester NHS Foundation Trust
🇬🇧Manchester, Lancashire, United Kingdom