Hypertension, Pulmonary Clinical Trial
— Levosim-PHOfficial title:
Levosimendan Administration in High Risk Cardiac Surgery Patients With Pulmonary Hypertension
Verified date | February 2023 |
Source | Aretaieion University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to examine the pharmacokinetics and pharmacodynamic properties of Levosimendan in cardiac surgery patients with pulmonary hypertension and impaired right ventricular function.
Status | Completed |
Enrollment | 45 |
Est. completion date | October 17, 2022 |
Est. primary completion date | October 17, 2022 |
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,
Boost KA, Hoegl S, Dolfen A, Czerwonka H, Scheiermann P, Zwissler B, Hofstetter C. Inhaled levosimendan reduces mortality and release of proinflammatory mediators in a rat model of experimental ventilator-induced lung injury. Crit Care Med. 2008 Jun;36(6):1873-9. doi: 10.1097/CCM.0b013e3181743e63. — View Citation
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, Rellia P, Thanopoulos A, Tsourelis L, Zarkalis D, Sfyrakis P, Antoniou T. Inhaled iloprost controls pulmonary hypertension after cardiopulmonary bypass. Can J Anaesth. 2002 Nov;49(9):963-7. doi: 10.1007/BF03016884. — 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
Zhang J, Gage EM, Ji QC, El-Shourbagy TA. A strategy for high-throughput analysis of levosimendan and its metabolites in human plasma samples using sequential negative and positive ionization liquid chromatography/tandem mass spectrometric detection. Rapid Commun Mass Spectrom. 2007;21(14):2169-76. doi: 10.1002/rcm.3046. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | change from baseline in blood levels of levosimendan | blood levels will be measured with liquid chromatography | 20 minutes, 6 hours, 12 hours, 24 hours and 80 hours after administration | |
Other | change from baseline in blood levels of interleukin-6 (IL-6) | blood levels will be measured with the enzyme linked immunosorbent assay (ELISA) | end of surgery, 6 hours, 12 hours and 24 hours after Intensive Care Unit (ICU) admission | |
Primary | change from baseline in mean pulmonary arterial pressure (MPAP) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Secondary | change from baseline in pulmonary vascular resistance (PVR) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Secondary | change from baseline in mean arterial pressure (MAP) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Secondary | change from baseline in systemic vascular resistance (SVR) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Secondary | change from baseline in pulmonary capillary wedge pressure (PCWP) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Secondary | change from baseline in cardiac output (CO) | a Swan-Ganz catheter will be used for hemodynamic measurements | 20 minutes after levosimendan administration, at the end of surgery and 2 hours after Intensive Care Unit (ICU) admission | |
Secondary | change from baseline in tricuspid annular plane systolic excursion (TAPSE) | transthoracic and transesophageal echocardiography will be used for echocardiographic measurements | 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration | |
Secondary | change from baseline in fractional area change | transthoracic and transesophageal echocardiography will be used for echocardiographic measurements | 20 minutes after levosimendan administration, at the end of surgery, 2 hours after Intensive Care Unit (ICU) admission and 80 hours after levosimendan administration |
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