跳至主要内容
临床试验/NCT01865773
NCT01865773已完成不适用

Role of HFR Cartridge in the Removal of Mediators of Inflammation and P-cresol in Hemodialysis Patients

Federico II University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
IL-6 removal by a single session of HFR-Supra

研究概览

简要总结

A major limitation of standard hemodialysis is that it does not clear the plasma from interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular risk in end stage renal disease (ESRD). In the present study, we evaluated whether these compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge. We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240 minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session. The proinflammatory activity of UFin and UFout was determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8 healthy volunteers and cultured in vitro for 24 hr.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HD patients undergoing three weekly haemodialysis > 1 year

排除标准

  • 未提供

结局指标

主要结局

IL-6 removal by a single session of HFR-Supra

时间窗: The evaluation will be performed for the duration of a single HFR session of 240 minutes

We studied the change in IL-6 circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared IL-6 levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session. The proinflammatory activity of UFin and UFout was determined by evaluating the changes that they induced in IL-6 mRNA expression and release in peripheral blood mononuclear cells (PBMC) collected from 8 healthy volunteers and cultured in vitro for 24 hr.

P-cresol removal by a single HFR session

时间窗: The evaluation will be performed for the duration of a single HFR session of 240 minutes

We studied the change in p-cresol circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared p-cresol levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session.

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Riccio

MD

Federico II University

研究点 (2)

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