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临床试验/NCT04318691
NCT04318691已完成不适用

Netosis in Mechanically Ventilated ICU Patients in Determination of Respiratory Infection Severity

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月7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
80
试验地点
1
主要终点
Acute respiratory distress syndrome occurrence

研究概览

简要总结

The study aims to evaluate the prognostic value of alveolar and blood NETosis in patients under mechanical ventilation and treated for an acute low-respiratory tract infection. The main outcome is the occurrence of an acute respiratory distress syndrome (ARDS) according to the Berlin definition.

详细描述

Neutrophils are the first line of defense against infectious injury. Among the numerous mechanisms involving the immune system, neutrophil extracellular traps (NETs) have been recently described as an additional way neutrophils are able to use to fight against bacteria. NETs are made of DNA and antimicrobial proteins. In the other hand, NETs promote coagulation and may contribute to evolution of severe pneumonia into acute respiratory distress syndrome.

The secondary objectives of the study include the research of the relation between blood NETosis and alveolar NETosis with:

  • the documentation of invasive pulmonary infection based on microbiological analysis criteria (which would be bacteria or viral) of LBA at admission to ICU;
  • the diagnosis value of usually used biomarkers: procalcitonin and C-reactive protein;
  • marbrure score at admission to ICU;
  • arterial lactatemia;
  • scores of gravity at admission IGSII and SOFA;
  • all-cause mortality at day-28;
  • duration of mechanical ventilation at day-28;
  • duration of amines at day-28;
  • developement of hemodynamic failure;
  • developement of pulmonary circulatory failure.

The study will include 1) 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure, 2) 10 control patients admitted to the ICU after a planned vascular surgery and 3) 10 healthy subjects.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • 未提供

排除标准

  • A/ For all subjets:
  • pregnancy,
  • nosocomial pneumonia,
  • no social health insurance,
  • neutropenia of any cause;
  • patient refusal.
  • B/ Exclusion criteria for acute respiratory failure patients:
  • no mechanical ventilation within the first 24 hours after admission to the ICU.

结局指标

主要结局

Acute respiratory distress syndrome occurrence

时间窗: at day-7

Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission

次要结局

  • Mortality(At day-28)
  • Duration of mechanical ventilation(At day-28)
  • IGSII score(At admission to ICU)
  • SOFA score(At admission to ICU)
  • Hemodynamic failure(At day-28)
  • Pulmonary circulation failure(At day-28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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