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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group A | Experimental | intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h |
|
| treatment group B | Placebo Comparator | treatment group B: control group with 5% glucose injection 2ml/h for 24h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levosimendan | Drug | Levosimendan 12.5mg was injected intravenously in a 5% glucose injection 50ml configuration at a rate of 2ml/h for 24 hours.The injection was performed at a constant rate of 2ml/h. If there was no significant hypotension or tachycardia, the injection was completed within 24h |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of right ventricular dysfunction occurrence within 48 hours after randomization. | 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. | From the time point of enrollment to 48 hours after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Right ventricular area fractional change (RV FAC) 48 hours after randomization | Right ventricular area fractional change (RV FAC)is a simple and repeatable ultrasound method for evaluating RV function. Methods: The RV end-diastolic area (RVEDA) and RV end-systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA*100%. | at the time of 48 hours after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongran Wu, MD | Contact | 027-85351606 | 974528836@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2022 | Feb 14, 2023 |
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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.
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| 5% glucose injection | Drug | 5% glucose injection 50ml configuration at a rate of 2ml/h for 24 hours.The injection was performed at a constant rate of 2ml/h. If there was no significant hypotension or tachycardia, the injection was completed within 24h |
|
| tricuspid annular plane systolic excursion(TAPSE) 48 hours after randomization | TAPSE is one of the most effective ultrasound methods for evaluating right ventricular function.Measurement method: TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of systole. | at the time of 48 hours after enrollment |
| Tricuspid annular systolic S' velocity (TS') | TS' is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI) | at the time of 48 hours after enrollment |
| Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) | RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and left ventricular(LV) end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound | at the time of 48 hours after enrollment |
| Pulmonary circulatory resistance (PVR) | Increased PVR can lead to deterioration of RV function.Pulse Doppler imaging (PWD) was used to obtain the pulmonary artery flow spectrum from the pulmonic valve on the short axial section of the parasternal great vessels. | at the time of 48 hours after enrollment |
| Sequential Organ Failure Assessment score | The higher the Sequential Organ Failure Assessment(SOFA) score, the higher the disease risk factor and the higher the mortality rate(The highest score is 24, while the lowest score is 0). | at the time of 48 hours after enrollment |
| cardiac index(CI) patients | CI is an important parameter to reflect the cardiac function of | at the time of 48 hours after enrollment |
| Central venous oxygen saturation(ScvO2) | The patient's blood was collected through a central venous catheter for blood gas analysis to calculate SCVO2 to indicate tissue perfusion | at the time of 48 hours after enrollment |
| systemic vascular resistance(SVR) | Peripheral vascular resistance is an important indicator of hemodynamics. It is not only a parameter reflecting cardiac afterload, but also a quantitative indicator reflecting the degree of patency of cerebrovascular microcirculation. | at the time of 48 hours after enrollment |
| Mean arterial pressure (MAP) | MAP represents peripheral organ perfusion pressure. | at the time of 48 hours after enrollment |
| Central venous pressure(CVP) | CVP is the pressure of the upper and lower vena cava entering the right atrium, measured by the upper and lower vena cava or the internal tube of the right atrium, which reflects the pressure of the right atrium, and is one of the main indicators for clinical observation of hemodynamics | at the time of 48 hours after enrollment |
| systemic vascular resistance index(SVRI) | SVRI=80*(MAP-CVP)/CI | at the time of 48 hours after enrollment |
| 28-day mortality | 28-day mortality after study entry | Day 28 after study entry |
| in-hospital mortality | Any death occurred during hospitalization(up to 90 days) | From the day patients admitted to hospital to the day death or discharge(up to 90 days) |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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