跳至主要内容
临床试验/NCT03014232
NCT03014232已完成不适用

Comparison Cytokine Clearance Between Sustained Low-Efficiency Diafiltration (SLED-f) Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients

Chulalongkorn University0 个研究点目标入组 16 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
IL-6 Clearance

研究概览

简要总结

Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).

详细描述

Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). Reductions of these cytokines have been reported to improve clinical outcomes. Online sustained low-efficiency diafiltration(SLED-f) using traditional high-flux(HF) dialyzer could remove some cytokines. Interestingly, the potential of enhancing cytokine removal by using newly designed high cut-off(HCO) dialyzer that could theoretically remove larger molecular weight solutes has never been studied in SLED-f before.This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f,n=8) and HF dialyzer(HF-SLED-f,n=8).

研究设计

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

  • Acute kidney injury stage 3

排除标准

  • Profound hemodynamic instability with more than one inotropic drug
  • Pregnancy
  • Breast-feeding
  • Delayed receiving antibiotic up to 6 hours after beginning of septic shock.

结局指标

主要结局

IL-6 Clearance

时间窗: At 30 minutes after the treatment was started

Simultaneous pre-and post-dialyzer blood samples from arterial and venous sampling ports were collected at 30 minutes after the treatment was started for determination of dialyzer clearances.

次要结局

  • Urea percentage of reduction ratio(At time 0-hour and 6-hour of the study SLED-f session)
  • Beta2-microglobulin percentage of reduction ratio(At time 0-hour and 6-hour of the study SLED-f session)
  • IL-10 Clearances(At 30 minutes after the treatment was started)
  • TNF-α Clearances(At 30 minutes after the treatment was started)
  • Intradialytic hypotension(During 6 hours of SLED-f session)
  • Albumin loss in spent dialysate(During 6 hours of SLED-f session)

研究者

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

Khajohn Tiranathanagul

Assistant Professor

Chulalongkorn University

相似试验