Effect of Citrate Dialysate on Vascular Calcification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Length of Calcified Artery Segments
研究概览
简要总结
The goal of this study is to determine whether hemodialysis with citrate slows the progression of vascular calcification. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured on mammograms that will be performed at 6-month intervals and additional blood samples will be obtained at 6-month intervals.
详细描述
Vascular calcification is a significant problem in dialysis patients that leads to poor outcomes. Currently there is no therapy that directly addresses this problem. Some of the dialysis solutions (dialysates) currently in use contain citrate, a potent inhibitor of calcium precipitation. In particular, citrate can bind to nascent hydroxyapatite crystals and prevent their propagation. Blood citrate levels are greater after dialysis with citrate dialysates than with non-citrate dialysates, which could slow vascular calcification. However, this has never been investigated. Prior research has shown that arterial calcification can be easily detected and reliably measured on routine digital mammograms, with sufficient sensitivity to follow progression. Mammography is more sensitive in detecting arterial calcification than other imaging and associated with far less radiation and cost. This will allow the researchers to detect differences between citrate and non-citrate dialysates in a safe and convenient way. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured by mammography every 6 months. The endpoint will be the difference in the rate of progression of breast arterial calcification (BAC) between dialysis with citrate and non-citrate dialysates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •hemodialysis patients with BAC on mammograms
排除标准
- •current warfarin use
- •severe hyperparathyroidism (likely to undergo parathyroidectomy in the next 2 years)
- •difficulty controlling serum calcium (likely to require changes in dialysate calcium concentration in the next 2 years)
- •life expectancy < 2 years
- •prisoners
- •inability to give consent
研究组 & 干预措施
Citrate Dialysate then Standard Dialysate
Participants receiving hemodialysis using a citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a non-citrate acid concentrate dialysate (standard dialysate) for the second year of the study.
干预措施: Citrate Dialysate (Device)
Citrate Dialysate then Standard Dialysate
Participants receiving hemodialysis using a citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a non-citrate acid concentrate dialysate (standard dialysate) for the second year of the study.
干预措施: Standard Dialysate (Device)
Standard Dialysate then Citrate Dialysate
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a citrate acid concentrate dialysate for the second year of the study.
干预措施: Citrate Dialysate (Device)
Standard Dialysate then Citrate Dialysate
Participants receiving hemodialysis using a non-citrate acid concentrate dialysate for the first year of the study, then receiving hemodialysis using a citrate acid concentrate dialysate for the second year of the study.
干预措施: Standard Dialysate (Device)
结局指标
主要结局
Length of Calcified Artery Segments
时间窗: 3 measurements during 12 months of treatment for each study period (up to 24 months for both years of the study)
Rate of progression of breast arterial calcification (BAC) is calculated by linear regression of 3 mammograms over one year in each treatment arm (Months 0, 6 and 12 versus Months 12, 18 and 24). Progression of calcification is quantified as the length of calcified artery segments per year, measured in millimeters. Slower progression of vascular calcification, indicated by lower values, is a desirable outcome.
次要结局
- Serum Ionized Calcium (iCa)(Pre-HD and Post-HD during each study period (up to 24 months for both years of the study))
- Serum Magnesium (Mg)(Pre-HD and Post-HD during each study period (up to 24 months for both years of the study))
- Plasma Citrate(Pre-HD and Post-HD during each study period (up to 24 months for both years of the study))