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临床试验/NCT02944279
NCT02944279已完成不适用

Neutrophil Elastase and Elafin as Prognostic Biomarker for Acute Respiratory Distress Syndrome

Peking University Third Hospital0 个研究点目标入组 500 人开始时间: 2011年1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
500
主要终点
ARDS development-Berlin definition

研究概览

简要总结

The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care unit (ICU) throughout the world. In recent years, much effort has been focused on the biological markers for their potential values to diagnose ARDS and outcomes.

ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability, which subsequently caused an influx of neutrophils into the interstitium and alveolar space. It was reported that the aggregation, adhesion activation and release proteases of neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the most crucial protease generated in neutrophil azurophilic granules, plays an important role in various inflammations, especially the lung injury. The destructive action of HNE on almost all extracellular matrix influences cell signaling through cleavage of surface receptors. Once released in circulation, HNE is rapidly inactivated by conjugation with PI3. This local inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the investigators plan to conduct a cohort study with repeated measures to examine the diagnostic and prognostic value of HNE and PI3 for ARDS.

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

  • 未提供

排除标准

  • Age <18 years
  • History of chronic lung diseases, such as interstitial pulmonary fibrosis or bronchiolitis
  • history of pneumonectomy
  • Treatment with immunomodulating therapy other than corticosteroids, such as granulocyte colony stimulating factor, cyclophosphamide, cyclosporine, interferon, or TNF-α antagonists
  • Presence of other immunodeficient conditions, such as HIV infection, leukemia, or neutropenia (absolute neutrophil count <1000/μl)
  • History of organs or bone marrow transplant other than autologous bone marrow transplant
  • Directive to withhold intubation
  • ICU stay duration<72h
  • Patient developed ARDS before ICU admission. Sepsis and septic shock were defined according to the Berlin definition

结局指标

主要结局

ARDS development-Berlin definition

时间窗: 60 days

ARDS survival

时间窗: 60 days

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

Xi Zhu

Professor

Peking University Third Hospital

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