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

NCT05768230 | Unknown Phase 2

• 1 other identifier: ARVD20220810
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Transesophageal Echocardiography; Acute Respiratory Distress Syndrome; Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Right ventricular area fractional change (RV FAC) 48 hours after randomization

  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

• Tricuspid annular systolic S' velocity (TS')

  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

• Pulmonary circulatory resistance (PVR)

  at the time of 48 hours after enrollment

Study Arms (2)

treatment group A

EXPERIMENTAL

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

Drug: levosimendan

treatment group B

PLACEBO COMPARATOR

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

Drug: 5% glucose injection

Interventions

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

treatment group A

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

treatment group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventricular Dysfunction, Right

Interventions

Simendan; Glucose

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Central Study Contacts

Yongran Wu, MD

CONTACT

027-85351606; 974528836@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 14, 2023
• Study Start: March 22, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2023

Record last verified: 2022-12

Locations

CN (1)