Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05768230
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-14
First Post:
2023-02-18
Brief Title:
Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RVDLevosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile forceIn 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 resistanceHowever the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficientTherefore 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 arealeft ventricular end-diastolic area RVEDALVEDA pulmonary circulation resistance PVR hemodynamics and mortality
Detailed Description:
Acute respiratory distress syndrome ARDS is often complicated by right ventricular dysfunction RVDthe 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 increasedCurrently there are very limited clinical drug treatment options for RVDLevosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile forceIn 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 failureAt 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 effectsHowever the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficientTherefore 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 arealeft ventricular end-diastolic area RVEDALVEDA pulmonary circulation resistance PVR RV-PA coupling hemodynamics and mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None