Clinical and Biological Markers in Ventilator-associated Pneumonia and the Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in cytokine levels in BAL fluid from day 1 to day 5 post-enrollment
研究概览
简要总结
In a recent experimental study, the investigators showed that the growth factor Activin A is expressed in the lungs of rats with the acute respiratory distress syndrome (ARDS) at levels that are comparable with those determined in the bronchoalveolar (BAL) lavage fluid from patients with ARDS. In the same study, the administration of the Activin A inhibitor Folistatin resulted in attenuation of the histological damage of the ARDS-afflicted rat lung.
The precise role of Activin A/Folistatin in acute respiratory failure associated with acute lung inflammatory pathology has not been elucidated yet. Therefore, the purpose of the present, observational study is to investigate the role of Activin A/Folistatin in respiratory failure due to ARDS and/or ventilator-associated pneumonia (VAP), also in relation with other biochemical markers, such as cytokines and surfactant-related proteins.
详细描述
Rationale Survival from the Acute Respiratory Distress (ARDS) has been associated with clinical (e.g. age, sepsis, and organ failure) and biological factors. The latter include inflammatory mediators (e.g. cytokines), factors of activation/damage of the capillary endothelium (e.g. von Willebrand factor) and the alveolar epithelium (e.g. intracellular adhesion molecule-1), and factors associated with the coagulation/fibrinolysis cascade (e.g. protein C). These biochemical markers have been previously associated with the duration of mechanical ventilation, the ARDS-induced organ dysfunction/failure, and the survival of the patients. A combination of biochemical and clinical markers might be useful as a prognostic tool in ARDS.
In a recent experimental study, the investigators showed that the growth factor Activin A is expressed in the lungs of rats with ARDS at levels that are comparable with those determined in the bronchoalveolar (BAL) lavage fluid from patients with ARDS. In the same study, the administration of the Activin A inhibitor Folistatin resulted in attenuation of the histological damage of the ARDS-afflicted rat lung.
The precise role of Activin A/Folistatin in acute respiratory failure associated with acute lung inflammatory pathology has not been elucidated yet. Therefore, the purpose of the present, observational study is to investigate the role of Activin A/Folistatin in respiratory failure due to ARDS and/or ventilator-associated pneumonia (VAP), in relation with the other biochemical markers.
Methods Patients The study protocol has been approved by the Institutional Review Board of Evaggelismos General Hospital, Athens, Greece. A study information sheet detailing the associated potential risks and benefits will be provided to a first degree relative of eligible patients. Subsequently, following a detailed discussion of the study with the investigator(s), a written informed consent will be requested.
Continuous monitoring of patients will include electrocardiographic lead II, intraarterial pressure [and/or cardiac index (PICCO plus, Pulsion Medical Systems, Munich, Germany) - in concordance with clinical indications] and peripheral oxygen saturation (SpO2). Maintenance of anesthesia will be achieved with intravenous midazolam or propofol and/or fentanyl or remifentanyl. Neuromuscular blockade (cisatracurium) will be used in concordance with recent recommendations, and/or as part of the treatment prescribed by the attending physicians. The follow-up of the patients will last for 60 days or until hospital discharge (if it occurs earlier than day 60 after study enrollment).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ventilator-associated pneumonia and/or ARDS.
- •PaO2 to fractional inspired oxygen (FiO2) of less than 400 mmHg.
- •Age 18-75 years.
- •Body weight of at least 40 Κg.
排除标准
- •Significant air leak.
- •Severe hemodynamic instability.
- •Heart disease.
- •Chronic obstructive pulmonary disease or asthma.
- •Intracranial hypertension.
- •Chronic interstitial lung disease.
- •Lung biopsy or lobectomy/pneumonectomy during current admission.
- •Prior lung or bone marrow transplantation.
- •Immunosuppression.
- •Bleeding diathesis and/or coagulation disturbances.
结局指标
主要结局
Change in cytokine levels in BAL fluid from day 1 to day 5 post-enrollment
时间窗: Days 1-5 post-enrollment
Change in surfactant protein C levels in BAL fluid from day 1 to day 5 post-enrollment
时间窗: Days 1-5 post-enrollment
Change in Activin A, levels in BAL fluid from day 1 to day 5 post-enrollment
时间窗: Days 1-5 post-enrollment
次要结局
- Mean arterial and central-venous pressure, and norepinephrine infusion rate at 09:00 a.m. of days 1-10 post-enrollment(Days 1-10 post-enrollment)
- Survival to hospital discharge(Days 1-60 (or until actual time point of hospital discharge) post-enrollment)
- Respiratory compliance and plateau airway pressure at 09:00 a.m. of days 1-10 post-enrollment(Days 1-10 post-enrollment)
- Organ Failure Free Days(Days 1-60 post-enrollment)
- PaO2/FiO2, PaCO2, pHa, and central-venous oxygen saturation at 09:00 a.m. of days 1-10 post-enrollment.(Days 1-10 post-enrollment)
研究者
Spyros D. Mentzelopoulos
Assistant Professor in Intensive Care Medicine
University of Athens