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临床试验/NCT02003326
NCT02003326终止不适用

Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg

研究概览

简要总结

The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

详细描述

Nowadays ARDS severity, and therapeutic efficiency are evaluated using PaO2/FiO2 ratio. Inflammation is a cornerstone of ARDS and the ratio is not a sufficiently accurate tool to predict the evolution of ARDS. A reproducible marker would be helpful to adapt the therapeutics and maybe limit their deleterious effects.

The investigators made the hypothesis that patients moderate to severe ARDS (comparable PaO2/FiO2 ratio) with a higher strain may have higher inflammation.

Moderate/severe ARDS will be ventilate with protective ventilation (low tidal volume and PEEP set to limit plateau pressure under 30cmH2O). Markers of inflammation will be measured in the broncho Alveolar Lavage the first day and in the blood the following days. Strain will be measured at the bedside using the nitrogen washout-washin. Markers of inflammation and strain will be analysed with ventilatory and oxygenation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Moderate to severe ARDS (Berlin Definition)
  • Acute beginning <1 week
  • PaO2/FiO2 ratio ≤ 200 after 24h mechanical ventilation with PEEP≥5cmH2O
  • Bilateral opacities on chest X-ray
  • Respiratory failure not fully explain by cardiac failure or fluid overload
  • Informed consent signed by the next of kin and secondarily by the patient when awake
  • Patient with social insurance
  • No Inclusion criteria
  • Age < 18
  • Pregnancy a pregnancy test will be done to women of childbearing age
  • Chronic obstructive pulmonary disease
  • Severe hypoxemia PaO2/FiO2 <50% with high PEEP
  • Immunosuppressive treatment
  • Immunodeficiency onco-hematology, HIV

排除标准

  • 未提供

研究组 & 干预措施

Inflammatory markers

Other

All patients with inclusion criteria (ARDS moderate and severe: Berlin definition) and absence of non inclusion criteria will have a broncho alveolar wash at day 0 and blood sample every three day to measure inflammatory markers. All patients will receive protective ventilation with low tidal volume and pressures limited (Pplat <30cmH2O). End-Expiratory Lung Volume and strain will be measured every 6 hours from the inclusion to the extubation.

干预措施: Inflammatory markers (Other)

结局指标

主要结局

measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg

时间窗: until the 13th day

measure of the number of hours spent with a PaO2/FiO2 ratio under 200mmHg : day 0,1,2,4,6,13

次要结局

  • Mortality at D28(at the 28th day)
  • Ventilatory free days at D28(at the 28th day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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