A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established on in-centre haemodiafiltration (HDF) for greater than 12 weeks with a minimum of 3 treatment sessions per week
- •Ability to consent
排除标准
- •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
研究组 & 干预措施
Medium Cut-Off Haemodialysis (Theranova)
Participants will receive medium cut-off haemodialysis treatment for 6 months in total (3 times per week treatment).
干预措施: Medium Cut-Off Haemodialysis (Device)
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).
干预措施: On-Line Haemodiafiltration (Device)
结局指标
主要结局
Change in endothelial function (composite of endothelial microvesicle levels, pro-inflammatory & pro-coagulant markers)
时间窗: 6 months
Change in vascular endothelial marker score (derived from multiple biomarkers)
次要结局
- Change in pulse wave velocity(6 months)
- Change in pre-dialysis serum albumin(3 & 6 months)
- Change in inter-dialytic urine volume(6 months)
- Change in heart-rate adjusted augmentation index (AI)(6 months)
- Change in components of pre-dialysis "middle molecule" panel(3 & 6 months)
- Change in Chalder fatigue scale(3 & 6 months)
- Change in pre-dialysis CRP(3 & 6 months)
- Change in number of phosphate binder medications(6 months)
- Cardiovascular mortality(6 months)
- Change in augmentation pressure (AP)(6 months)
- Change in components of cytokine panel(3 & 6 months)
- Change in numbers blood pressure medications(6 months)
- Change in IPOS-Renal (Integrated Palliative Care Outcome Score)(3 & 6 months)
- Change in self-sported dialysis recovery time(3 & 6 months)
- All-cause mortality(6 months)
- Change in Advanced Glycation End Products (AGE)(6 months)
- Hospitalisation episodes(6 months)