Using Transesophageal Echocardiography to Evaluate the Effect of Levosimendan on Patients With Acute Respiratory Distress Syndrome Associated With Right Ventricular Dysfunction During Mechanical Ventilation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The rate of right ventricular dysfunction occurrence within 48 hours after randomization.
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD), Acute cor pulmonale is the most serious form of ARDS complicated with RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile force.In 2016, the European Society of Cardiology issued recommendations for the management of acute right heart failure, stating that levosimendan can improve right ventriculo-pulmonary artery coupling by both increasing right heart contractility and reducing pulmonary vascular resistance.However, the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficient.Therefore, this study intends to use transesophageal ultrasound to evaluate right ventricular function, reduce the limitation of poor right ventricular window in transthoracic echocardiography, and conduct a multi-center randomized controlled study to further explore the effects of levosimendan on right ventricular function in ARDS patients, such as tricuspid ring systolic displacement (TAPSE) and tricuspid ring systolic displacement velocity (S '). Effects of right ventricular area change fraction (RV FAC), right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA), pulmonary circulation resistance (PVR), hemodynamics and mortality.
详细描述
Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD),the incidence can be as high as 64%, Acute cor pulmonale is the most serious form of ARDS complicated with RVD. The prognosis of ARDS patients with RVD is worse and the risk of death would be significantly increased.Currently, there are very limited clinical drug treatment options for RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile force.In 2016, the European Society of Cardiology issued recommendations for the management of acute right heart failure, stating that levosimendan can improve right ventriculo-pulmonary artery coupling by both increasing right heart contractility and reducing pulmonary vascular resistance. Levosimendan is therefore recommended to be given priority over dobutamine in the treatment of acute right heart failure.At present, there are also relevant clinical studies reporting that levosimendan can be used in acute right heart failure caused by different causes, including a single center randomized controlled study reporting that levosimendan can do work in the right ventricle of patients with sepsis ARDS, and has beneficial hemodynamic effects.However, the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficient.Therefore, this study intends to use transesophageal ultrasound to evaluate right ventricular function, reduce the limitation of poor right ventricular window in transthoracic echocardiography, and conduct a multi-center randomized controlled study to further explore the effects of levosimendan on right ventricular function in ARDS patients, such as tricuspid ring systolic displacement (TAPSE) and tricuspid ring systolic displacement velocity (S '). Effects of right ventricular area change fraction (RV FAC), right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA), pulmonary circulation resistance (PVR), RV-PA coupling, hemodynamics and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who agree to participate in this clinical trial and sign informed consent
- •Age 18-80 years old, gender unlimited
- •Patients with ARDS(According to the diagnostic criteria of ARDS in Berlin 2012) requiring mechanical ventilation; Acute right ventricular dysfunction due to ARDS
排除标准
- •Pregnant or lactating women;
- •Chronic cardiac insufficiency, pulmonary hypertension and/or right ventricular enlargement caused by chronic cardiopulmonary disease, cardiogenic shock or after major cardiac surgery before ARDS;
- •right ventricular myocardial infarction;
- •Uncorrected hypotension, hypoxemia and hypercapnia, or acid-base balance disturbance
- •Mechanical ventilation driving pressure >=18cmH2O before randomization
- •Rapid arrhythmia;
- •pericardial tamponade;
- •Pulmonary embolism;
- •severe renal insufficiency;
- •severe liver insufficiency;
- •Failure to sign informed consent;
- •known allergy to the test drug and control drug;
- •Patients who have participated in other clinical trials within 30 days
研究组 & 干预措施
treatment group A
intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h
干预措施: levosimendan (Drug)
treatment group B
treatment group B: control group with 5% glucose injection 2ml/h for 24h
干预措施: 5% glucose injection (Drug)
结局指标
主要结局
The rate of right ventricular dysfunction occurrence within 48 hours after randomization.
时间窗: From the time point of enrollment to 48 hours after enrollment
Right ventricular dysfunction(RVD) is diagnosed when the results of an echocardiogram show one of the following, including: tricuspid annular plane systolic excursion(TAPSE)\<16 mm, right ventricular fractional area change(RV FAC)\<35% or systolic velocity of the lateral tricuspid valve annulus( RV S')\<10 cm/s.
次要结局
- Central venous oxygen saturation(ScvO2)(at the time of 48 hours after enrollment)
- Central venous pressure(CVP)(at the time of 48 hours after enrollment)
- tricuspid annular plane systolic excursion(TAPSE) 48 hours after randomization(at the time of 48 hours after enrollment)
- cardiac index(CI) patients(at the time of 48 hours after enrollment)
- 28-day mortality(Day 28 after study entry)
- in-hospital mortality(From the day patients admitted to hospital to the day death or discharge(up to 90 days))
- Tricuspid annular systolic S' velocity (TS')(at the time of 48 hours after enrollment)
- Right ventricular area fractional change (RV FAC) 48 hours after randomization(at the time of 48 hours after enrollment)
- Pulmonary circulatory resistance (PVR)(at the time of 48 hours after enrollment)
- Sequential Organ Failure Assessment score(at the time of 48 hours after enrollment)
- Mean arterial pressure (MAP)(at the time of 48 hours after enrollment)
- Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)(at the time of 48 hours after enrollment)
- systemic vascular resistance(SVR)(at the time of 48 hours after enrollment)
- systemic vascular resistance index(SVRI)(at the time of 48 hours after enrollment)