Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Plasma calcium level evaluation (mEq/l)
研究概览
简要总结
This study aimed to evaluate the effect on the calcium balance of a concentrate with 1 mM citrate and locate the equivalent concentration of calcium (Ca_eq) at a concentration of 3 mM acetate and traditional with 1.5 mM calcium in HD. The secondary objective is to evaluate the performance in the medium term of purifying the concentrate with 1 mM citrate and Ca_eq, compared to traditional concentrated with 3 mM acetate and 1.5 mM calcium in HD.
详细描述
Primary Objective The primary objective of this study is to find the formulation of calcium (1.50, 1.65 and 1.75 mM) in the bath with 1 mM citrate which allows the equivalence of calcium balance (Ca_eq) in a sitting HD compared to traditional concentrated with 3 mM of calcium acetate and 1.5.
Secondary objectives
- Evaluate the purifying performance of small and medium-sized molecules in HD with concentrated with 1 mM citrate and Ca_eq compared to traditional concentrated with 3 mM calcium acetate and 1.5.
- Observe the effects on hemodynamic of the concentrate through the variation of the pre and post-dialysis blood pressure and intradialytic symptoms (cramps, hypotension, headache).
- Evaluate the variations of the parameters of mineral metabolism: Predialytic values of PTH, alkaline phosphatase treatments with concentrated Cit (1 mM citrate and Ca_eq) and concentrated with traditional Ac (3 mM calcium acetate and 1.5).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Patients clinically stable.
- •age> 18 years.
- •HD therapy for more than 3 months.
- •good vascular access native functionality that enables real blood flow of at least 250 ml / min.
排除标准
- •Patients with the features listed below may not be enrolled in this survey:
- •Life expectancy <6 months.
- •residual diuresis> 500 ml / day.
结局指标
主要结局
Plasma calcium level evaluation (mEq/l)
时间窗: 6 months
Calcium balance from data of the calcium ion and total dialysate compartment. Complete blood count pre-and post-dialysis, total Proteins pre-and post-dialysis, will be collected from the patient's blood sitting in the middle of the week. Biochemical data from the dialysis fluid and spent dialysate sitting in the middle of the week:Calcium ion (EGA) and total in the dialysis fluid in the following times: 5, 120, end of dialysis; Calcium ion (EGA) and total effluent in the following times: 5, 120, end of dialysis
次要结局
- Evaluate purifying performance of small and medium-sized molecules in HD (Kt/V)(6 months)
- Evaluation of variations of the parameters of mineral metabolism(6 months)
研究者
Carlo Maria Guastoni
DPT Director
Azienda Ospedaliera, Ospedale Civile di Legnano