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临床试验/NCT03288922
NCT03288922已完成不适用

Comparison of Protein-bound Toxins Removals Between Limited Blood Flow Online Hemodiafiltration Using Super High-flux Dialyzer and High-Efficiency Online Hemodiafiltration With High-flux Dialyzer: An Randomized Crossover Trial

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年10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
10
试验地点
2
主要终点
pCS percentage of reduction ratio

研究概览

简要总结

High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance protein-bound toxin and middle molecular toxin removal and improve patient survival. Unfortunately, the majority of patients could not reach that high BF because of vascular access issue. This randomized crossover study was conducted to compare these uremic toxin removals between the new modality (limited BF OL-HDF with super high-flux dialyzer) and the control (high-efficiency OL-HDF). The OL-HDF patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks.

详细描述

Elevated protein-bound toxins including p-cresol (pCS) and indoxyl sulfate (IDS) as well as middle-molecular toxins such as beta2-microglobulin (B2M) which could not be removed by hemodialysis (HD) are obviously correlated with high mortality. High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance pCS, IDS, and B2M removal and improve patient survival. Unfortunately, the majority of patients could not reach that high BF because of vascular access issue. We innovated the OL-HDF modality for this limited BF situation by integrating the novel super high-flux membrane dialyzer (SHF; PES-17Dα, Nipro Corporation, Japan) into pre-dilution OL-HDF. This randomized crossover study was conducted to compare the uremic toxin removals between the new modality (limited BF OL-HDF with SHF) and the control (high-efficiency OL-HDF). The OL-HDF patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks. Removals of pCS and IDS as well as small and middle molecule toxins were compared. The pCS and IDS were measured by high performance liquid chromatography. The dialysate albumin loss and patient safety were also monitored.

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 patients treated with thrice-a-week OL-HDF for at least 6 months
  • Residual urine < 100 mL/day

排除标准

  • Active cardiovascular disease
  • Active malignancy
  • Pregnancy
  • Breast-feeding

研究组 & 干预措施

Limited BF OL-HDF with SHF

Experimental

Limited blood flow pre-dilution online hemodiafiltration using super high-flux dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of protein-bound toxin removals with the control period.

干预措施: Limited BF OL-HDF with SHF (Procedure)

High-efficiency OL-HDF

Active Comparator

High-efficiency post-dilution online hemodiafiltration using standard high-flux dialyzer was assigned as the control period.

干预措施: High-efficiency OL-HDF (Procedure)

结局指标

主要结局

pCS percentage of reduction ratio

时间窗: At time 0-hour and 4-hour of the study online hemodiafiltration session

Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session of each modality. pCS levels were measured by high-performance liquid chromatography (HPLC). The percentage of reduction ratio were calculated from the before and ending samples.

次要结局

  • Beta2-microglobulin percentage of reduction ratio(At time 0-hour and 4-hour of the study online hemodiafiltration session)
  • Albumin loss in spent dialysate(During 4 hours of online hemodiafiltration session)
  • IDS percentage of reduction ratio(At time 0-hour and 4-hour of the study online hemodiafiltration session)

研究者

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

Khajohn Tiranathanagul

Associate Professor

Chulalongkorn University

研究点 (2)

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