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

Primary Purpose

Transesophageal Echocardiography, Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
levosimendan
5% glucose injection
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transesophageal Echocardiography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment group A

treatment group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%.
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.
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)
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
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.
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).
cardiac index(CI) patients
CI is an important parameter to reflect the cardiac function of
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
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.
Mean arterial pressure (MAP)
MAP represents peripheral organ perfusion pressure.
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
systemic vascular resistance index(SVRI)
SVRI=80*(MAP-CVP)/CI
28-day mortality
28-day mortality after study entry
in-hospital mortality
Any death occurred during hospitalization(up to 90 days)

Full Information

First Posted
February 18, 2023
Last Updated
March 12, 2023
Sponsor
Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05768230
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 22, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transesophageal Echocardiography, Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group A
Arm Type
Experimental
Arm Description
intravenously injected levosimendan 12.5mg with 5% glucose injection 50ml configuration at 2ml/h for 24h
Arm Title
treatment group B
Arm Type
Placebo Comparator
Arm Description
treatment group B: control group with 5% glucose injection 2ml/h for 24h
Intervention Type
Drug
Intervention Name(s)
levosimendan
Intervention Description
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
Intervention Name(s)
5% glucose injection
Intervention Description
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
Primary Outcome Measure Information:
Title
The rate of right ventricular dysfunction occurrence within 48 hours after randomization.
Description
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.
Time Frame
From the time point of enrollment to 48 hours after enrollment
Secondary Outcome Measure Information:
Title
Right ventricular area fractional change (RV FAC) 48 hours after randomization
Description
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%.
Time Frame
at the time of 48 hours after enrollment
Title
tricuspid annular plane systolic excursion(TAPSE) 48 hours after randomization
Description
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.
Time Frame
at the time of 48 hours after enrollment
Title
Tricuspid annular systolic S' velocity (TS')
Description
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)
Time Frame
at the time of 48 hours after enrollment
Title
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
Description
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
Time Frame
at the time of 48 hours after enrollment
Title
Pulmonary circulatory resistance (PVR)
Description
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.
Time Frame
at the time of 48 hours after enrollment
Title
Sequential Organ Failure Assessment score
Description
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).
Time Frame
at the time of 48 hours after enrollment
Title
cardiac index(CI) patients
Description
CI is an important parameter to reflect the cardiac function of
Time Frame
at the time of 48 hours after enrollment
Title
Central venous oxygen saturation(ScvO2)
Description
The patient's blood was collected through a central venous catheter for blood gas analysis to calculate SCVO2 to indicate tissue perfusion
Time Frame
at the time of 48 hours after enrollment
Title
systemic vascular resistance(SVR)
Description
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.
Time Frame
at the time of 48 hours after enrollment
Title
Mean arterial pressure (MAP)
Description
MAP represents peripheral organ perfusion pressure.
Time Frame
at the time of 48 hours after enrollment
Title
Central venous pressure(CVP)
Description
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
Time Frame
at the time of 48 hours after enrollment
Title
systemic vascular resistance index(SVRI)
Description
SVRI=80*(MAP-CVP)/CI
Time Frame
at the time of 48 hours after enrollment
Title
28-day mortality
Description
28-day mortality after study entry
Time Frame
Day 28 after study entry
Title
in-hospital mortality
Description
Any death occurred during hospitalization(up to 90 days)
Time Frame
From the day patients admitted to hospital to the day death or discharge(up to 90 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongran Wu, MD
Phone
027-85351606
Email
974528836@qq.com
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongran WU, master
Phone
18627004016
Ext
027-85351607
Email
974528836@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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