Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome: the IVOLIA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence and evolution of right heart failure during ARDS
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is an inflammatory injury of the lungs caused by various serious illnesses, such as a bacterial or viral lung infection. It is treated by artificial ventilation with the application of positive pressure. Pulmonary injury, coupled with artificial ventilation, can lead to right heart failure which hinders the ejection of blood to the pulmonary circulation. Modern mechanical ventilation modalities have reduced the frequency ("incidence") of this right heart failure in acute respiratory distress syndrome. A large-scale study has shown this a few years ago. However, the evolution of right heart failure during artificial ventilation, and the consequences it has on the patient's cardiovascular status are poorly determined. This study is conducted to improve knowledge in this area. In adult patients hospitalized in intensive care presenting acute respiratory distress syndrome, the investigators will collect the data recorded on cardiac ultrasound, doses of cardiovascular drugs as well as variables reflecting hemodynamic status and cell oxygenation. Data will be collected during the course of ARDS and mechanical ventilation, as well as after weaning from artificial ventilation.
详细描述
During acute respiratory distress syndrome (ARDS), lung damage, coupled with positive pressure artificial ventilation, can lead to failure of the right ventricle by modifying its loading conditions. The "protective" modalities used today to ventilate these patients have reduced the incidence of this right heart failure in ARDS. However, the evolution of right heart failure during mechanical ventilation, and its consequence on the hemodynamic state of the patient are poorly determined. The aim of this study is to improve knowledge in this area.The main objective of the current project is to describe the incidence of right heart failure in patients with ARDS placed on artificial ventilation and its evolution over time. The secondary objectives are to describe the simultaneous evolution of the hemodynamic state, the use of cardiovascular drugs and the variables of tissue oxygenation, to describe the phenotypes of patients presenting with right heart failure during ARDS in function of ultrasound, hemodynamic and tissue oxygenation characteristics, to describe the association of these different phenotypes with the prognosis, to describe the risk factors for these different phenotypes and to describe the influence on right heart failure during ARDS on factors related to the patient's volume status.
In adult patients hospitalized in intensive care presenting with ARDS, the investigators will collect data recorded during the first 24 hours, after 48-96 hours, on day 5-7 and within 48 hours after extubation. The investigators will collect ventilatory and hemodynamic data, data provided by cardiac ultrasound, vasopressor and inotropic drug doses and tissue oxygenation variables.
This is an observational multicenter study, in which the investigators plan to include 500 patients over a total period of 24 months.
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
- 否
入选标准
- •Age ≥18 years old
- •Hospitalization in intensive care undergoing mechanical ventilation
- •Presence of ARDS according to the current consensus definition (Berlin definition)
- •Performance of at least one echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day, and within 48 hours of extubation
排除标准
- •Pregnancy Poor echogenicity preventing reliable measurement of the dimensions of the right and left ventricles.
研究组 & 干预措施
Patients with ARDS under mechanical ventilation
- Age ≥18 years old
- Hospitalization in intensive care
- Presence of ARDS according to the current consensus definition
结局指标
主要结局
Incidence and evolution of right heart failure during ARDS
时间窗: From enrollment to the end of the treatment at 8 weeks
Interpretation of echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day and after extubation.
次要结局
- The temporal evolution of the haemodynamic status(From enrollment to the end of treatment at 8 weeks)
- Phenotypic description of patients affected by right heart failure during ARDS(From enrollment to the end of treatment at 8 weeks)
- Association of these different phenotypes with the prognosis(From enrollment to the end of the treatment at 8 weeks)
- Describe the risk factors for the occurrence of different phenotypes of right heart failure during ARDS(From enrollment to the end of treatment at 8 weeks)
- Effects of right ventricular failure on tests and indices of preload dependence using mechanical ventilation(From enrollment to the end of treatment at 8 weeks)
- Describe the effect of norepinephrine and/or vasopressin on the pulmonary circulation(From enrollment to the end of treatment at 8 weeks)
研究者
Xavier Monnet
Professor
Bicetre Hospital