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临床试验/NCT07466459
NCT07466459Enrolling By Invitation不适用

Optimisation of Solute Removal and Water Usage in Paediatric Haemodialysis

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
10
试验地点
1
主要终点
Extraction Ratio

研究概览

简要总结

Children receiving chronic haemodialysis are typically treated with dialysis machines designed for adult patients. As a result, some devices do not allow the ideal blood or dialysate flow rates to be set for paediatric use. In addition, the optimal dialysate-to-blood flow ratio for maximising solute removal while minimising water consumption remains poorly defined.

The aim of this study is to quantify the dialyser extraction ratio and clearance across different dialysis modalities and a range of dialysate-to-blood flow ratios. Blood and dialysate samples are collected at the blood inlet, blood outlet, and dialysate outlet lines, and concentrations of various uraemic toxins-spanning a range of molecular weights-are measured to calculate solute clearances.

详细描述

Children undergoing haemodialysis are enrolled in the study. During a mid-week dialysis session, three dialysis modalities are applied sequentially for 10-15 minutes each: haemodialysis (HD), predilution haemodiafiltration (pre-HDF), and postdilution haemodiafiltration (post-HDF). For each modality, the dialysate-to-blood flow ratio is adjusted to approximately 1.0, 1.5, and 2.0.

For each setting, blood samples are collected from the blood inlet and outlet lines, and dialysate samples are taken from the spent dialysate line. All sampling is performed within the first hour of the dialysis session.

All samples are analysed for a range of uraemic toxins, including small water-soluble solutes, middle molecules, and protein-bound toxins. Using inlet and outlet blood concentrations, the extraction ratio is calculated for each setting. Based on the dialysate flow rate, total water usage for a full dialysis session is estimated. Together, these calculations allow determination of the optimal dialysate-to-blood flow ratio that provides the highest dialyser clearance with the lowest relative water consumption.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • not older than 18 years old
  • at least three months of stable hemodialysis

排除标准

  • a non well-functioning vascular access
  • infections at the study week

研究组 & 干预措施

dialysis settings

Experimental

In each participant and in a consecutive way, different dialysis modalities and dialysate to blood flow ratios are set.

干预措施: blood and dialysate sampling (Other)

结局指标

主要结局

Extraction Ratio

时间窗: During the first hour of one midweek dialysis session, different dialysis flows and modalities are set for the time needed to take the samples.

Extraction ratio is calculated from dialyzer inlet and outlet toxin concentrations for different dialysis settings. Dialysis efficiency, based on extration ratio, is related to the corresponding water usage.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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