Hypertension, Pulmonary Clinical Trial
— levos-milrOfficial title:
Comparison of Intravenous Levosimendan and Inhalational Milrinone in High Risk Cardiac Patients With Pulmonary Hypertension
The aim of this study is to examine and compare the effect of Levosimendan and Milrinone administered intravenously and via inhalation respectively in cardiac surgery patients with pulmonary hypertension and right ventricular dysfunction.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - patients with pulmonary hypertension due to left ventricular dysfunction based on echocardiographic diagnosis preoperatively - elective cardiac surgery Exclusion Criteria: - primary pulmonary hypertension - thromboembolic disease - chronic obstructive pulmonary disease - emergency surgery - redo surgery - inability to consent to the study |
Country | Name | City | State |
---|---|---|---|
Greece | Onassis Cardiac Surgery Center | Athens |
Lead Sponsor | Collaborator |
---|---|
Aretaieion University Hospital |
Greece,
Elhassan A, Essandoh M. Inhaled Levosimendan for Pulmonary Hypertension Treatment During Cardiac Surgery: A Novel Application to Avoid Systemic Hypotension. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1169-1170. doi: 10.1053/j.jvca.2018.11.039. Epub 2018 Nov 28. No abstract available. — View Citation
Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92. — View Citation
Hansen MS, Andersen A, Nielsen-Kudsk JE. Levosimendan in pulmonary hypertension and right heart failure. Pulm Circ. 2018 Jul-Sep;8(3):2045894018790905. doi: 10.1177/2045894018790905. Epub 2018 Jul 6. — View Citation
Kundra TS, Nagaraja PS, Bharathi KS, Kaur P, Manjunatha N. Inhaled levosimendan versus intravenous levosimendan in patients with pulmonary hypertension undergoing mitral valve replacement. Ann Card Anaesth. 2018 Jul-Sep;21(3):328-332. doi: 10.4103/aca.ACA_19_18. — View Citation
Theodoraki K, Thanopoulos A, Rellia P, Leontiadis E, Zarkalis D, Perreas K, Antoniou T. A retrospective comparison of inhaled milrinone and iloprost in post-bypass pulmonary hypertension. Heart Vessels. 2017 Dec;32(12):1488-1497. doi: 10.1007/s00380-017-1023-2. Epub 2017 Jul 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from baseline in mean pulmonary arterial pressure (MPAP) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in pulmonary vascular resistance (PVR) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in mean arterial pressure (MAP) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in systemic vascular resistance (SVR) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in pulmonary capillary wedge pressure (PCWP) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in cardiac output (CO) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in tricuspid annular plane systolic excursion (TAPSE) | transthoracic and transesophageal echocardiography will be used for echocardiographic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in fractional area change | transthoracic and transesophageal echocardiography will be used for echocardiographic measurements | 20 minutes after vasodilator administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Primary | length of ICU stay | duration of patient stay in ICU in days | postoperatively, an average period of 7-10 days | |
Primary | hospitalization time | duration of hospital stay after surgery in days | postoperatively, up to 20 days after the operation |
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