Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Effect of treatment on serum calcification propensity, measured by T50
研究概览
简要总结
The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 111 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female hemodialysis patients ≥ 18 years of age
- •Negative pregnancy test of female patients in child-bearing age
- •The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
- •Start of chronic hemodialysis treatment ≥ 3 months ago
- •HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
- •Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
- •T50 ≥ 200 minutes.
排除标准
- •Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
- •History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
研究组 & 干预措施
Mg first
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
干预措施: Bicarbonate (Device)
Bicarbonate first
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
干预措施: Bicarbonate (Device)
Bicarbonate first
Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase
干预措施: Magnesium (Device)
Mg first
Receives MgCl2 first, MgCl2 and Bicarbonate in second phase
干预措施: Magnesium (Device)
结局指标
主要结局
Effect of treatment on serum calcification propensity, measured by T50
时间窗: 7 weeks
T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)
次要结局
- Number of participants with treatment-related adverse events(7 weeks)