Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in pulse wave velocity at the three different haemoglobin levels
研究概览
简要总结
Dialysis patients suffer from many problems with blood vessels and this is even more so for patients with the added complication of diabetes. Diabetics have a number of reasons for vascular disease and one of the new areas of research is looking at the cells that line the blood vessels, called endothelial cells. It is thought that the number of red blood cells in the blood (haemoglobin concentration) affects the function of these cells. There is very little information available on what haemoglobin level is best for dialysis patients. As diabetics account for almost 40% of dialysis patients worldwide it is important to understand the effect different haemoglobin levels will have on the blood vessels.
Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels are affected by different haemoglobin concentrations [Hb] in dialysis patients.
详细描述
This project is going to ask dialysis patients (both diabetic and non-diabetic) to undergo a series of tests at three different time points over a one year period: a baseline set of tests, tested when haemoglobin is maintained at 130-140g/L and repeat the tests when haemoglobin is maintained at 105-115g/L. The current recommendation for haemoglobin is 110-120g/L. Patients will not be required to take any study medication but a specialist kidney doctor, using their usual medications of iron and erythropoietin therapy, will change their haemoglobin levels.
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
- •Aged 18-80 years
- •Patients receiving either conventional haemodialysis 3-4 x week, for a duration of > 6 months or peritoneal dialysis for a duration >6 months
- •Stable dialysis access for at least 3 months (Permcath / PTFE / AVF)
- •On erythropoietin and iron therapy, with stable [Hb] x 2 months (105 - 135g/L)
排除标准
- •Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to study
- •Patients with dysrhythmias
- •Pre dialysis SBP> 180 mmHg on > 2 times within a 2 week period
- •Between dialysis weight gain > 5% of body weight (if evident > 2 times/ 2 week period)
- •Soft tissue ulcers
- •Non traumatic amputations
- •Unstable cardiac function: ischaemic or non ischaemic events requiring modification of therapy, or admission to hospital within 3 months of study start: according to clinical discretion
- •Planned operative procedures within 6 months of study start (including Transplant, CABG, PTCA, vascular surgery)
- •Clinical inability to comply with testing
- •Malignancy (active / under treatment)
- •Known hypo-responsiveness to ERT (>200U/kg/wk)
- •Evidence of chronic gastrointestinal bleeding
- •Inadequate dialysis (PRU < 65% or KT/V < 1.2)
- •Participation in investigational study within last 3 months
结局指标
主要结局
Change in pulse wave velocity at the three different haemoglobin levels
次要结局
未报告次要终点