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临床试验/NCT06116656
NCT06116656终止不适用

Changes in Host Gene Expression to Differentiate Between Systemic Inflammation and Infection After Major Surgery

St. Antonius Hospital4 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
61
试验地点
4
主要终点
Postoperative infection

研究概览

简要总结

Changes in host gene expression may provide additional information to diagnose postoperative infection and improve outcome after surgery. This study aims to validate the early diagnostic performance of specific gene signatures for differentiating infection from non-infected SIRS or uncomplicated postoperative course in blood sampes of adult patients undergoing major noncardiac surgery.

详细描述

Rationale: Differentiation between the systemic inflammatory response syndrome (SIRS) and infection after surgery is challenging. Consequent diagnostic uncertainty may result in delayed diagnosis and interventions to prevent organ dysfunction or eventually death. Changes in host gene expression may provide additional information to diagnose postoperative infection and improve outcome after surgery.

Objective

To validate the early diagnostic performance of specific gene signatures1 for differentiating infection from non-infected SIRS or uncomplicated postoperative course.

Study design: A prospective observational multicenter study. Study population: Adult patients undergoing major noncardiac surgery. Main study parameters/endpoints: Main study parameters are specific gene signatures. Main study endpoint is postoperative infection and SIRS.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient blood samples will be drawn for analysis on the following time points: after induction for anaesthesia, directly postoperative and on postoperative day 1 - 7. For each sample 2.5 ml of blood is taken. In a total of 9 samples this results in a cumulative volume of 22.5 ml. Whenever possible, blood samples will be drawn simultaneously with routine perioperative laboratory testing. In case of admission to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Major noncardiac surgery with infection risk >20%

排除标准

  • Age <18 years
  • Emergency surgery
  • Inability to provide informed consent.

结局指标

主要结局

Postoperative infection

时间窗: 30 days

Infection after surgery

次要结局

  • Postoperative sepsis(30 days)
  • Postoperative SIRS(30 days)

研究者

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

dr. P. Noordzij

associate professor

St. Antonius Hospital

研究点 (4)

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