Clinical trial NCT05768230: Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV
Official title: Using Transesophageal Echocardiography to Evaluate the Effect of Levosimendan on Patients With Acute Respiratory Distress Syndrome Associated With Right Ventricular Dysfunction During Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Transesophageal Echocardiography
Acute Respiratory Distress Syndrome
Right Ventricular Dysfunction
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to treatment group A: intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h, or treatment group B: control group with 5% glucose injection 2ml/h for 24h.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The rate of right ventricular dysfunction occurrence within 48 hours after randomization.
timeFrame: From the time point of enrollment to 48 hours after enrollment
Secondary outcomes:
measure: Right ventricular area fractional change (RV FAC) 48 hours after randomization
timeFrame: at the time of 48 hours after enrollment
measure: tricuspid annular plane systolic excursion(TAPSE) 48 hours after randomization
timeFrame: at the time of 48 hours after enrollment
measure: Tricuspid annular systolic S' velocity (TS')
timeFrame: at the time of 48 hours after enrollment
measure: Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
timeFrame: at the time of 48 hours after enrollment
measure: Pulmonary circulatory resistance (PVR)
timeFrame: at the time of 48 hours after enrollment
measure: Sequential Organ Failure Assessment score
timeFrame: at the time of 48 hours after enrollment
measure: cardiac index(CI) patients
timeFrame: at the time of 48 hours after enrollment
measure: Central venous oxygen saturation(ScvO2)
timeFrame: at the time of 48 hours after enrollment
measure: systemic vascular resistance(SVR)
timeFrame: at the time of 48 hours after enrollment
measure: Mean arterial pressure (MAP)
timeFrame: at the time of 48 hours after enrollment
measure: Central venous pressure(CVP)
timeFrame: at the time of 48 hours after enrollment
measure: systemic vascular resistance index(SVRI)
timeFrame: at the time of 48 hours after enrollment
measure: 28-day mortality
timeFrame: Day 28 after study entry
measure: in-hospital mortality
timeFrame: From the day patients admitted to hospital to the day death or discharge(up to 90 days)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: