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临床试验/NCT05861700
NCT05861700已完成不适用

The Effect of Bicarbonate Profiling in Dialysis Fluid on Phosphate Removal During Hemodialysis and Blood pH

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
The blood phosphorus concentration change in hemodialysis patient

研究概览

简要总结

Hyperphosphatemia is still an unresolved problem among hemodialysis patients and significantly increases the risk of death from cardiovascular diseases. Research to date has not answered the question of whether dialysate bicarbonate concentration profiling can improve phosphate removal and its concentration without negative impact on the acid-base balance. This study addressed this issue.

Twenty stable hemodialysis patients will enroll to a four-week study during which different dialysate bicarbonate concentration profiles will be used each week. Each patient will undergo the following profiles (one-week periods): Treatment A - stable dialysate bicarbonate concentration Dbic 35 mmol/L during the whole HD session, Treatment B - Dbic 35 mmol/L for the first two hours and Dbic 30 mmol/L for the next two hours and Treatment C - the opposite mid-HD change Dbic from 30 to 35 mmol/L and one week wash-out period between Treatment B and C. We will collect blood samples each hour during the session and one hour after HD completion.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • stable general condition
  • hemodialysis more than 3 months
  • Dialysis 3 times a week/ 4 hours +/- 20 minutes
  • Dialysis with arterio-venous fistulas
  • bicarbonate titer before hemodialysis 22-24 mmol/l

排除标准

  • diabetes mellitus
  • inflamation processes
  • usage of sevelamer last month
  • utrafiltration during dialysis more than 2500 ml

结局指标

主要结局

The blood phosphorus concentration change in hemodialysis patient

时间窗: 4 weeks

The blood phosphorus concentration change in hemodialysis patient using dialysate bicarbonate profiling

次要结局

  • The maintaining the acid-base balance in accordance with applicable recommendations.(4 weeks)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Monika Wieliczko

Clinical Doctor

Medical University of Warsaw

研究点 (2)

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