The Effect of Increasing Dialysate Magnesium on Serum Calcification Propensity in Subjects With End-Stage Renal Disease Treated With Haemodialysis - A Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Between-group difference in serum calcification propensity at follow-up
研究概览
简要总结
The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum calcification propensity in subjects with end-stage renal disease treated with haemodialysis.
详细描述
Patients with end-stage renal disease (ESRD) have a 20-fold increased risk of cardiovascular mortality compared to the general population. Arterial stiffness, likely due to vascular calcification (VC), has been shown to predict cardiovascular mortality in ESRD. Serum calcification propensity (T50) is a novel biomarker, which is believed to reflect the propensity toward ectopic calcification (e.g. VC). Increasing serum magnesium (sMg) should increase T50, which might in turn reduce the formation of VC in patients with ESRD. A cheap and easy way of achieving this would be to increase the concentration of Mg in the dialysate (dMg) of patients with ESRD treated with haemodialysis (HD).
The investigators wish to conduct a randomised controlled double-blind clinical trial to examine whether increasing dMg will improve T50 in subjects with ESRD treated with HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Treatment with maintenance haemodialysis for more than 3 months.
- •Dialysate magnesium of 0.5 mmol/L (standard concentration).
- •Serum magnesium < 1.2 mmol/L on average of previous measurements within the last 3 months.
- •Women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test.
- •Written informed consent.
排除标准
- •Treatment with peritoneal dialysis.
- •Parathyroid hormone > 66 ρmol/L.
- •Previous parathyroidectomy.
- •Current treatment with magnesium containing medication or supplements.
- •Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Dialysate magnesium 1.0 mmol/L
Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.
干预措施: Dialysate magnesium (1.0 mmol/L) (Other)
Dialysate magnesium 0.5 mmol/L
Maintain dialysate magnesium at 0.5 mmol/L.
干预措施: Dialysate magnesium (0.5 mmol/L) (Other)
结局指标
主要结局
Between-group difference in serum calcification propensity at follow-up
时间窗: 4 weeks
次要结局
- Within-group change in serum calcification propensity(2 weeks)
- Within-group change and between-group difference in serum magnesium(4 weeks)
- Change in serum magnesium after intervention(2 weeks)
- Within-group change and between-group difference in serum parathyroid hormone(4 weeks)
- Change in serum parathyroid hormone after intervention(2 weeks)
- Change in fibroblast growth factor 23 during intervention(4 weeks)
- Incidence of intradialytic hypotension during intervention(4 weeks)
研究者
Iain Bressendorff
MD
Nordsjaellands Hospital