HaemoDialysis Interventions to REduce Multi-Organ Dysfunction and Effect on Quality of Life (HD-REMODEL) Assessed by MRI Scanning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in cerebral perfusion during standard HD and thermocontrolled HD
研究概览
简要总结
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The effects of a standard prescription haemodialysis (dialysate temperature 37 C) will be compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius) offers a way to overcome this to regulate thermal balance during dialysis and achieve a neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters will be standardised between treatment arms using blood volume monitoring (BVM) and clinical assessments.
详细描述
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The Primary objectives are to investigate the difference in cardiac perfusion, structure and function between standard HD and thermocontrolled HD using magnetic imaging techniques, to observe the the changes in renal perfusion and oxygenation within one dialysis session and the changes to cerebral perfusion within one dialysis session.
The secondary objectives are to investigate the difference in cerebral perfusion, structure, oedema and function between standard HD and thermocontrolled HD, the difference in renal perfusion and oxygenation between standard HD and thermocontrolled HD and the differences in visual acuity and cognitive assessment across a dialysis session and over a dialysis treatment course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80, male and female
- •Informed consent signed and dated by study patient and investigator/authorised physician
- •Average (4 weeks prior to recruitment) Ultrafiltration volumes ≥ 0.5 litres/ dialysis session
- •Receiving dialysis via an arteriovenous fistula
- •Must be able to follow simple instruction in English (on safety grounds for MRI scans) and be able to understand the nature and requirements of the study
- •Stable dialysis prescription
- •CKD5 (Chronic kidney disease) patients having renal replacement therapy with haemodialysis/ haemodiafiltration (>90 days)
排除标准
- 未提供
研究组 & 干预措施
Standard HD
HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions
干预措施: HD, Magnetic Resonance Imaging (MRI) scans (Other)
Thermocontrolled HD
HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions
干预措施: HD, Magnetic Resonance Imaging (MRI) scans (Other)
结局指标
主要结局
Change in cerebral perfusion during standard HD and thermocontrolled HD
时间窗: after 2 and 4 weeks after randomisation
Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL
Change in cardiac output during standard HD and thermocontrolled HD
时间窗: after 2 and 4 weeks after randomisation
Change in cardiac output during standard HD and thermocontrolled HD using Phase Contrast Magnetic Resonance Imaging (PC-MRI)
Change in renal perfusion during standard HD and thermocontrolled HD
时间窗: after 2 and 4 weeks after randomisation
Change in renal perfusion using Arterial Spin Labelling (ASL) and renal artery flow using PC-MRI
次要结局
未报告次要终点