跳至主要内容
临床试验/NCT01923961
NCT01923961已完成不适用

Impact of an Increased Sodium Chloride Concentration in the Infusion Fluid of Predilution Hemodiafiltration on the Removal of Protein-Bound Uremic Toxins

EXcorLab GmbH2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
EXcorLab GmbH
入组人数
8
试验地点
2
主要终点
Removal of Para-cresylsulfate

研究概览

简要总结

An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid at a target NaCl concentration and the effect on the removal of protein-bound toxins will be determined. Comparisons will be made to standard hemodialysis and hemodiafiltration.

详细描述

Eight maintenance dialysis patients will be enrolled in a prospective, randomized, crossover trial. HD will be compared with online pre-dilution HDF and HDF at increased plasma ionic strength. The ionic strength will be increased using an infusion fluid with hypertonic [Na+] by isovolumetric adding of a 5000 mmol/L NaCl solution. Blood and dialysate flowrates (250 and 575 mL/min, respectively), treatment time (240 min), and high-flux dialyser (surface area 2.1 sqm, PUREMA H) will be always kept identical. Anticoagulation with standard or fractionated heparin will be unchanged adopted from the patients' routinely used regimen. In both HDF modes, the infusion flow rate will be 125 mL/min. In HDF at increased plasma ionic strength, the infusate [Na+] will be adjusted to approach 240 mmol/L in plasma entering the dialyser and the dialysate [Na+] will be set at the technically feasible minimum of 130 mmol/L. Blood samples will be drawn from the arterial and venous blood lines and, if applicable, from the blood tubing connecting the two dialyzers at 0, 15, 30, 60, 120, 180, and 240 min. Samples at 240 min will be drawn after reducing the blood flow rate to 50 mL/min for 30 s and the dialysate flow turned off. A fraction of the spent dialysate will be continuously collected.

Removal of the free and total fraction of para-cresyl sulfate and indoxyl sulfate will be determined by reduction ratios, dialytic clearances and mass in dialysate

Hemocompatibility will be assessed by WBC and platelet counts, free Hb, LDH, C5a and TAT. [Na+] will be monitored in both arterial (i.e. before NaCl infusion) and venous blood of the extracorporeal system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • End-stage renal disease
  • Maintenance hemodialysis or hemodiafiltration for more than 3 months
  • Stable clinical condition
  • > 18 years

排除标准

  • Life expectancy less than 1 year
  • Pregnancy
  • Active infectious disease

结局指标

主要结局

Removal of Para-cresylsulfate

时间窗: 4 hours

Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention

Removal of Indoxylsulfate

时间窗: 4 hours

Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention

次要结局

  • Plasma Sodium Concentrations(4 hours)
  • Hemocompatibility(4 hours)

研究者

发起方
EXcorLab GmbH
申办方类型
Other
责任方
Sponsor

研究点 (2)

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