Effect of Dialysate Bicarbonate Prescription on Serum Calcification Propensity and Calciprotein Particles in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- T50-Laboratory Test for measuring calcification
研究概览
简要总结
This is a single-center, prospective, proof-of-priciple, pilot study in 24 end-stage renal disease patients on chronic hemodiaysis.
详细描述
This single-arm, proof-of-principle study will be conducted at the dialysis facility of the Ordensklinikum Linz Elisabethinen Hospital. The dialysate bicarbonate prescription will be decreased from standard of care (usually 35mmol/l) in a stepwise fashion (2 mmol/l per change) to 27 mmol/l and subsequentially increased in a stepwise fashion (2 mmol/l per change) to 37 mmol/l over the course of 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- •chronic (≥3 months) treatment with hemodialysis or hemodiafiltration
- •stable clinical condition
排除标准
- •inability to provide informed consent
- •dialysis treatment less than thrice weekly
- •morbid obesity (body mass index >40 kg/m2)
- •chronic inflammation (C reactive protein >10 mg/dL, reference: <0.5 g/dL)
- •current immunosuppressive medication,
- •severe chronic obstructive pulmonary disease (COPD stage III or IV)
- •history of severe hypercapnia or hypoxemia
- •overt congestive heart failure
- •history of severe hypokalemia (<3.0 mmol/l) or hyperkalemia (>6.5 mmol/L) within 3 months prior to study inclusion.
结局指标
主要结局
T50-Laboratory Test for measuring calcification
时间窗: 6 Weeks
The intra-individual difference of T50-times between low (27 mmol/l) and high (37 mmol/l) dialysate bicarbonate prescription.
次要结局
- CPP Levels(6 Weeks)
研究者
Prim. Priv. Doz. Dr. Daniel Cejka
Principal Investigator
Elisabethinen Hospital