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临床试验/NCT02098356
NCT02098356已完成不适用

Intradialytic Acid-base Changes and Organic Anion Production With High Versus Low Bicarbonate Hemodialysis

Albert Einstein College of Medicine2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Pre-dialysis serum bicarbonate

研究概览

简要总结

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens.

详细描述

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months

排除标准

  • Use of oral alkali within the previous month
  • Hospitalization within the previous month
  • Inability to provide written informed consent
  • Plans for kidney transplant in the next 2 months
  • Planned change in phosphate binder therapy within the next month
  • Pregnancy, or planned pregnancy in the next 2 months

研究组 & 干预措施

Low bicarbonate

Experimental

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

干预措施: Low Bicarbonate (Other)

结局指标

主要结局

Pre-dialysis serum bicarbonate

时间窗: 5 weeks

Change in predialysis bicarbonate

次要结局

  • interleukin-6(5 weeks)
  • serum beta-hydroxybutyrate(5 weeks)
  • beta-hydroxybutyrate clearance(5 weeks)
  • Dialysis symptom questionnaire(5 weeks)
  • serum free fatty acids(5 weeks)
  • Time to recover from dialysis(5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Abramowitz

Assistant Professor

Albert Einstein College of Medicine

研究点 (2)

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