NCT02494843已完成不适用
Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF
研究概览
简要总结
The purpose of this study is to characterise, in detail, the cardiac structure, function and perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to ascertain if haemodiafiltration provides relative myocardial protection compared to conventional haemodialysis.
详细描述
Trial Configuration: Non-blinded crossover pilot study Setting: Secondary care Sample size estimate: This is a pilot study therefore power calculations are not appropriate. A group size of 12 participants has been selected for feasibility.
Number of participants: 12 patients to complete study Description of interventions
- 6 sessions of conventional haemodialysis each lasting 4 hours
- 6 sessions of online haemodiafiltration each lasting 4 hours
- 2 sessions of Cardiac MRI each lasting 6 hours in total to take place around 6th session of dialysis Randomisation and blinding: This is an open study. Statistical methods: All continuous variables will be tested for normality. The primary and continuous secondary endpoints will be compared between the two modalities using a paired t test or Wilcoxon signed rank test as appropriate. The association between categorical variables will be tested using the Chi squared or Fischer's Exact test. An alpha error at 0.05 will be judged as significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Able to give informed consent
- •CKD5 on chronic haemodialysis
- •Receiving dialysis via an arteriovenous fistula
- •Must be able to follow simple instruction in English (on safety grounds for MRI scans)
排除标准
- •Change in ideal dry weight in 4 weeks prior to recruitment
- •Instability on dialysis in 4 weeks prior to recruitment leading to either:
- •Emergency medical attention
- •Infusion of additional fluid
- •Loss in consciousness
- •Arrhythmia
- •Chest pain
- •Dialysed via a synthetic line or graft
- •Qa < 500ml/min
- •NYHA Stage IV heart failure
- •Active infection or malignancy
- •Contraindication to MRI scanning including claustrophobia
- •Mental incapacity to consent
- •Pregnancy or planning pregnancy
结局指标
主要结局
The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF
时间窗: 2 week
次要结局
- The change in segmental cardiac perfusion during conventional HD and HDF(2 week)
- Reported tolerability of cardiac MRI scanning whilst having dialysis(On 2 MRI study days)
- Serum markers of cardiac damage, renal, liver function, clotting, full blood count(2 weeks)
- The change in global and segmental cardiac function as measured by phase-contrast MRI(2 week)
研究者
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