BicMag Study - Improving Mineral Buffering Capacity in Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 91
研究概览
简要总结
The BicMag study is a prospective, randomized, controlled cross-over study that aims to examine the potential additive effect of a dialysate enriched with both bicarbonate and magnesium on mineral buffering capacity in the blood of chronic hemodialysis patients.
详细描述
We hypothesize that simultaneously increasing bicarbonate and magnesium concentrations in the dialysate will enhance mineral buffering capacity more effectively than either intervention alone. Ninty-one chronic hemodialysis patients will be enrolled in this randomized, controlled, cross-over study. Using a balanced Latin square design, participants will undergo four sequential 3-week treatment phases with the following dialysates:
- D-Standard: 32 mmol/L bicarbonate, 0.5 mmol/L magnesium
- D-Bic: 37 mmol/L bicarbonate, 0.5 mmol/L magnesium
- D-Mag: 32 mmol/L bicarbonate, 1 mmol/L magnesium
- D-BicMag: 37 mmol/L bicarbonate, 1 mmol/L magnesium. The primary endpoint is calciprotein crystallization time (T50); the secondary endpoint is serum levels of endogenous calciprotein particles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Prevalent patients (≥ 3 months) treated with thrice weekly hemodialysis or hemodiafiltration
- •Dialysate calcium of 1.25 mmol/l
排除标准
- •Inability to provide informed consent
- •Currently participating in another investigational device or drug study or non-interventional study
- •Dialysate calcium other than 1.25 mmol/l
- •Parathyroidectomy planned during the study
- •Elective living-donor kidney transplant scheduled during the study period
- •Therapy with bisphosphonates within the past 12 months or denosumab within the past 6 months
- •Pregnant or nursing (lactating) women
研究者
Prim. Priv. Doz. Dr. Daniel Cejka
Head of Nephrology
Elisabethinen Hospital