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临床试验/NCT03955887
NCT03955887终止不适用

Mitochondrial Dysfunction of Alveolar and Circulating Immune Cells During Acute Respiratory Distress Syndrome: Impact of Infectious Aggression and Alveolar Stretching as a Result of Mechanical Ventilation.

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年6月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
1
主要终点
Active mitochondria content of alveolar macrophages

研究概览

简要总结

Sepsis leads to a deregulated host response that can lead to organ failure. During sepsis, experimental and clinical data suggest the occurrence of mitochondrial dysfunctions, particularly in circulating muscle and monocytes, which may contribute to organ failure and death.

Lower respiratory infection is the leading cause of death from infectious causes. Mechanical ventilation (MV) is required in 20% of cases of bacterial pneumopathy with Streptococcus pneumoniae (S.p.) , with mortality reaching 50%. There are then frequently criteria for acute respiratory distress syndrome (ARDS), combining bilateral lung involvement and marked hypoxemia.

Cyclic stretching of lung cells induced by MV causes sterile inflammation and tissue damage (i.e. ventilator-induced lung injury [VILI]), which can cause cellular dysfunction that alter the immune response, particularly during ARDS. This is why the application of a so-called protective MV is then required. However, this does not prevent about one-third of patients from showing signs of alveolar overdistension, as evidenced by an increase in motor pressure (MP) (MP≥ 15 cmH2O), associated with an increase in mortality.

The deleterious effects of MV could be explained by the occurrence of mitochondrial abnormalities. Indeed, the cyclic stretching of lung cells leads to dysfunction in the respiratory chain and the production of free oxygen radicals (FOS), altering membrane permeability. These phenomena could promote VILI, facilitate the translocation of bacteria from the lung to the systemic compartment and lead to alterations in immune response.

In our model of S.p. pneumopathy in rabbits, animals on MV develop more severe lung disorders (lack of pulmonary clearance of bacteria, bacterial translocation in the blood, excess mortality), compared to animals on spontaneous ventilation (SV). Intracellular pulmonary mitochondrial DNA (mtDNA) concentrations, a reflection of the mitochondrial pool, are significantly decreased in ventilated rabbits compared to SV rabbits and in infected rabbits compared to uninfected rabbits. At the same time, the mitochondrial content of circulating cells decreased early (H8) in all infected rabbits, but was only restored in rabbits in SV, those who survived pneumonia (Blot et al, poster ECCMID 2015, submitted article). These data suggest an alteration in the mechanisms that restore mitochondrial homeostasis (mitochondrial biogenesis and mitophagy) during the dual infection/MV agression, which may explain the observed excess mortality. Other work by our team illustrates the importance of these phenomena by showing in a mouse model of polymicrobial infection that inhibition of mitophagia in macrophages promotes survival (Patoli et al, in preparation). Human data on this subject are non-existent.

The phenomena of mitochondrial dysfunction nevertheless deserve to be explored in humans during the combined MV/pneumopathy aggression in order to understand its possible impact on the effectiveness of the host's immune response. In a personalized medicine approach, these data would open up prospects for targeted therapies, capable of activating mitochondrial biogenesis and/or modulating mitophagia, to prevent organ dysfunction and mortality during severe CALs treated with antibiotic therapy.

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

  • Patient who has given his non-opposition (or non-opposition obtained from close relative of ventilated patients, who will be informed as soon as possible).
  • Adult patient
  • Group 1: patient with:
  • Acute pneumonitis defined by: Signs and acute symptoms of pneumonia (new or worsening within the last 7 days), at least 2 of which are:
  • Purulent sputum
  • Chest pain
  • Temperature < 35°C or ≥ 38°C And a new pulmonary radiological infiltrate (x-ray or CT scan on admission)
  • Not acquired under mechanical ventilation
  • Complicated from ARDS according to the new Berlin definition, Chest x-ray finding bilateral parenchymal opacities not fully explained by pleural effusions, nodules or atelectasis. Respiratory distress not explained by cardiac dysfunction or overfilling. An echocardiogram will be performed in case of diagnostic uncertainty. PaO2/FiO2 report < 300 and PEP ≥ 5 cmH2O
  • Requiring the use of MV.
  • With a diagnostic BAL performed within 72 hours of the start of the MV
  • Group 2: Patients:
  • No fever during the last 15 days (reported or measured ≥ 37.8°C).
  • Not under MV,
  • Undergoing BAL for a reason other than acute infection (e.g. chronic interstitial syndrome, nodule or lung mass).

排除标准

  • Patient not affiliated to the national health insurance system
  • Major under judicial protection
  • Pregnant, parturient or breastfeeding woman
  • Known primary or secondary immune deficiency (radiotherapy, chemotherapy, immunosuppressive therapy or systemic corticosteroid therapy (>10mg/day prednisone equivalent for more than 7 days) within 6 months before inclusion, HIV infection, primary cellular immune deficiency)
  • Patients with treatment known to modulate mitochondrial function, biogenesis and/or mitophagia (chloroquine, hydroxychloroquine, rapamycin, carbamazepine, resveratrol, metformin, sildenafil)
  • Patients with pulmonary fibrosis or cystic fibrosis known to be associated with mitochondrial alterations

研究组 & 干预措施

Experimental

Patients with severe acute lung disease requiring mechanical ventilation

干预措施: bronchoalveolar lavage fluid (BAL) (Biological)

Experimental

Patients with severe acute lung disease requiring mechanical ventilation

干预措施: Venous blood (Biological)

Control

Patients receiving routine bronchoalveolar lavage for a pathology not suspected of acute infection

干预措施: bronchoalveolar lavage fluid (BAL) (Biological)

Control

Patients receiving routine bronchoalveolar lavage for a pathology not suspected of acute infection

干预措施: Venous blood (Biological)

结局指标

主要结局

Active mitochondria content of alveolar macrophages

时间窗: Through study completion, an average of 19 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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