Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Calcification propensity (T50 test)
研究概览
简要总结
The goal of this clinical trial is to find out if using a citrate-based dialysate with added magnesium during hemodialysis can help slow down or prevent the hardening of blood vessels (vascular calcification) in adults on long-term dialysis.
The main questions the study will try to answer are:
Does citrate-based dialysate with magnesium improve the blood's ability to prevent calcium buildup (measured by a test called T50) compared to acetate-based dialysate?
Does it modify magnesium, calcium and parathyroid hormone (PTH) levels in the blood?
Does it lower the chances of heart problems or death?
Researchers will compare two groups: one will receive acetate-based dialysate, and the other will receive citrate-based dialysate with magnesium.
Participants will:
Receive one of the two types of dialysate during their regular hemodialysis sessions for 12 months
Have regular blood tests
Be monitored for any heart problems and for overall health during the study
详细描述
Vascular calcification is a common and serious complication in patients receiving long-term hemodialysis. Dialysate composition may influence its progression. Acetate, a weak acid, has traditionally been added to dialysate to maintain chemical stability and prevent precipitation of calcium or magnesium bicarbonate salts. However, long-term acetate exposure has been associated with adverse effects, prompting the search for safer alternatives.
Citrate is a promising substitute that may help reduce vascular calcification by maintaining a neutral calcium balance. Nevertheless, it can lower magnesium levels in the blood (hypomagnesemia), which might counteract its benefits. This supports the idea of adding magnesium to citrate-based dialysate.
This is a prospective, randomized, open-label clinical trial designed to compare the effects of acetate-based dialysate versus citrate-based dialysate with magnesium supplementation in adult hemodialysis patients. Participants will be enrolled and followed for 12 months.
The primary outcome will be changes in calcification propensity (T50). Secondary outcomes include changes in serum magnesium, calcium, and PTH levels, as well as the incidence of cardiovascular events and all-cause mortality.
The findings may help identify a safer and more effective dialysate composition to improve cardiovascular outcomes in this patient population.
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
- None
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
- •Adults (≥18 years old) on maintenance hemodialysis for more than 3 months
- •Clinically stable patients with a well-functioning vascular access
- •Residual urine output ≤ 250 mL/day
- •Able and willing to provide written informed consent
排除标准
- •Known allergy or intolerance to any component of the dialysates
- •Active malignancy or infectious/inflammatory disease
- •Planned living donor kidney transplant before study completion
- •Current treatment with vitamin K antagonists (coumarins)
- •Severe hypocalcemia or poorly controlled secondary hyperparathyroidism
- •Any condition that, in the investigator's judgment, contraindicates participation or affects study compliance
研究组 & 干预措施
Acetate dialysate
Fresenius SmartBag 211.5
干预措施: Acetate dialysate (Device)
Citrate dialysate
Fresenius SmartBag CA 211.5-0.75
干预措施: Citrate dialysate with magensium supplementation (Device)
结局指标
主要结局
Calcification propensity (T50 test)
时间窗: Baseline and at 3, 6, 9, and 12 months
T50 is a laboratory test that measures the serum's intrinsic capacity to inhibit calcium-phosphate precipitation, reflecting the overall propensity for vascular and soft tissue calcification. Higher T50 values indicate greater calcification resistance.
次要结局
- Parathyroid hormone (PTH) levels(Baseline and at 3, 6, 9, and 12 months)
- Serum vitamin D levels(Baseline and at 3, 6, 9, and 12 months)
- Serum magnesium levels(Baseline and at 3, 6, 9, and 12 months)
- Total serum calcium levels(Baseline and at 3, 6, 9, and 12 months)