跳至主要内容
临床试验/NCT04193865
NCT04193865已完成不适用

Hemofilter Life Span and Filtration of Inflammatory Markers in Patients Receiving Extracorporeal Life Support And/or Continuous Renal Replacement Therapy

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年1月9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
10
试验地点
1
主要终点
Cytokine concentrations over time (every 12 hours for the entire course of CRRT)

研究概览

简要总结

The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.

详细描述

Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Neonatal or pediatric patients receiving ECLS (>2 kilograms and >34 weeks gestation)
  • CRRT utilized during ECLS course
  • For the secondary endpoints comparing CRRT-mediated cytokine filtration in patients receiving ECLS with concurrent CRRT to patients receiving CRRT alone (no ECLS), the investigators will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS). Patients will be eligible for entry into this study if they meet all of the following criteria:
  • Neonatal or pediatric patients receiving CRRT
  • Exclusion criteria:
  • Those patients with inability or unwillingness of legal guardian/representative to give informed consent

排除标准

  • 未提供

结局指标

主要结局

Cytokine concentrations over time (every 12 hours for the entire course of CRRT)

时间窗: Cytokine concentrations over time every 12 hours for the entire course of CRRT through study completion, up to 12 months

Quantify cytokine concentrations, specifically interferon (IFN)- γ, interleukin (IL)-1β, IL-6, IL-8, IL-10, IL-12p70, tumor necrosis factor (TNF)-α (all to result in concentrations in pg/ml), in pre-CRRT filter serum, post-CRRT filter serum, and ultrafiltrate (UF) using electrochemiluminescene assay and cytometric bead array and determine how age of the CRRT filter influences filtration of these cytokines.

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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Hemofilter Life Span, ECLS And/or CRRT | 临床试验