Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transesophageal Echocardiography Acute Respiratory Distress Syndrome Right Ventricular Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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treatment group A

intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h

Group Type EXPERIMENTAL

levosimendan

Intervention Type 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

treatment group B

treatment group B: control group with 5% glucose injection 2ml/h for 24h

Group Type PLACEBO_COMPARATOR

5% glucose injection

Intervention Type 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

Interventions

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levosimendan

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

Intervention Type DRUG

5% glucose injection

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No