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临床试验/NCT04226430
NCT04226430已完成不适用

Effect of a Novel Extracorporeal Cytokine Apheresis Method on Endocan, Copeptin and Interleukin-6 Levels in Sepsis: an Observational Prospective Study.

University of Gaziantep0 个研究点目标入组 34 人开始时间: 2016年6月1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
主要终点
Effect of a novel extracorporeal cytokine apheresis method on endocan levels in sepsis

研究概览

简要总结

Background: There is still an evident need for useful biomarkers and effective therapeutic approaches regarding the challenging management of sepsis. The aim of the study is to evaluate the effect of each Cytosorb hemoadsorption therapy course on blood levels of inflammatory biomarkers of sepsis including endocan, copeptin, interleukin-6, procalcitonin, C-reactive protein.

详细描述

This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy between June 1st, 2016 and June 30th, 2017. Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Exclusion criteria of the study were: (i) cardiovascular disease, (ii) multiple traumas, (iii) malignancies, (v) incomplete clinical data.

Approval of the ethical committee (ethical committee approval number 2018/04-02) was obtained. Written informed consent was taken from each patient or their next-of-kin. Patient demographics including age, gender, and origin of sepsis were recorded. Arterial blood samples were taken from patients before and immediately after the Cytosorb therapy course.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy (Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))

排除标准

  • cardiovascular disease,
  • multiple traumas
  • malignancies
  • incomplete clinical data.

结局指标

主要结局

Effect of a novel extracorporeal cytokine apheresis method on endocan levels in sepsis

时间窗: 13 months

The effect of each Cytosorb hemoadsorption therapy course on blood levels of endocan, an inflammatory biomarker of sepsis.

Effect of a novel extracorporeal cytokine apheresis method on copeptin levels in sepsis

时间窗: 13 months

The effect of each Cytosorb hemoadsorption therapy course on blood levels of copeptin, an inflammatory biomarker of sepsis.

Effect of a novel extracorporeal cytokine apheresis method on interleukin-6 levels in sepsis

时间窗: 13 months

The effect of each Cytosorb hemoadsorption therapy course on blood levels of interleukin-6, an inflammatory biomarker of sepsis.

次要结局

未报告次要终点

研究者

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

Berna Kaya Ugur

Assistan Professor

University of Gaziantep

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