跳至主要内容
临床试验/NCT00925483
NCT00925483Unknown不适用

Decreasing Dialysis Cardiovascular Risk: Daily Versus Longer Treatments

Dallas VA Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
LVM change per Cardiac MRI

研究概览

简要总结

Given the known increased risk of heart disease in hemodialysis patients, this study aims to evaluate the change in both size and function of the heart by using cardiac magnetic resonance imaging (MRI) in patients undergoing either daily long (4 hours, 6 times weekly), daily short (2 hours 6 times weekly), or alternate day conventional (4 hours, 3 times weekly) and alternate day long (8 hours, 3 times weekly) dialysis for 6 months from randomization. The patients are randomly put in the groups based on predetermined randomization schedule and the cardiologist trained in cardiac MRI readings is blinded to the patient treatment schedule. Given that changes in heart function may be seen with cardiac imaging techniques within 6 months, the expectation is that groups on daily treatment may have better outcome for this parameter as changes in volume and blood pressure may also be affected in a positive way in patients on daily dialysis.

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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End stage renal disease patients on hemodialysis

排除标准

  • Weight > 350 lbs
  • Known poor dialysis and or treatment compliance
  • Unable to come for daily treatments if randomization occurs in this group
  • Prognosis less than 6 months
  • Difficulty in tolerating dialysis and possibility of discontinuation of dialysis before 6 months

研究组 & 干预措施

alternate day long

Experimental

alternate day long (8 hours, 3 times weekly) dialysis for 6 months

干预措施: dialysis (Procedure)

alternate day conventional

Experimental

alternate day conventional (4 hours, 3 times weekly) dialysis for 6 months

干预措施: dialysis (Procedure)

daily short

Experimental

daily short (2 hours 6 times weekly) dialysis for 6 months

干预措施: dialysis (Procedure)

daily long

Experimental

daily long (4 hours, 6 times weekly) dialysis for 6 months

干预措施: dialysis (Procedure)

结局指标

主要结局

LVM change per Cardiac MRI

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Fed

研究点 (1)

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