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临床试验/NCT06723223
NCT06723223已完成不适用

Clinical Validation of a Combined Equilibration Test in Patients on Peritoneal Dialysis

Lund University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Reliability of the combined peritoneal equilibrium test

研究概览

简要总结

Peritoneal membrane function tests such as the traditional peritoneal equilibrium test (PET) aid in the assessment of various peritoneal membrane functions, and are widely used in clinical practice to guide dialysis prescription, and also to monitor the integrity of the peritoneal membrane over time. Traditional tests do however have several shortcomings such as being time consuming, complex, and having a low reliability. Also, present functional tests often provide limited information such as small solute transfer rates, which means that other functional changes go unnoticed.

The present study investigates the reliability of a novel short (60 min) test, with the potential of replacing complex and time-consuming conventional tests. The novel test provides a comprehensive assessment on both water- and solute transfer across the peritoneal membrane, including the osmotic conductance to glucose (OCG), small solute diffusive conductance (in terms of the diffusive surface to diffusion length ratio, A0/Δx), and also macromolecular transport and apparent fluid absorption. In contrast to conventional tests, multiple fill volumes may be used and results are also applicable to all glucose strengths used in conventional peritoneal dialysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Peritoneal dialysis treatment duration of at least 1 month
  • No recent peritonitis (a minimum of 1 month since the last peritonitis)

排除标准

  • Pregnancy
  • Participant unable to provide informed consent
  • Peritonitis
  • Other acute infections

结局指标

主要结局

Reliability of the combined peritoneal equilibrium test

时间窗: All interventions need to be completed within one month.

Reliability of the novel test will be assessed using the Intraclass Correlation Coefficient (ICC) evaluating consistency and repeatability of key continuous measurements (osmotic conductance to glucose, diffusive conductance, albumin clearance, and apparent fluid absorption) across the two different test occasions (Day 1 and Day 2)

次要结局

  • Comparison of the Traditional vs. Combined Peritoneal Equilibrium Test(All interventions are performed within one month.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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