Study Results
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Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2020-10-17
2022-10-17
Brief Summary
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Detailed Description
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In this study, Levosimendan will be administered in patients with pulmonary hypertension undergoing cardiac surgery. 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. The drug will be administered in different doses to define the dose at which Levosimendan administration reduces pulmonary vascular resistance and pressure without causing significant reduction of systemic vascular resistance and pressure. The anti-inflammatory effect of the perioperative use of Levosimendan in cardiac surgery will also be studied.
In this setting, 45 patients with PH caused by left sided heart disease, will be assigned into three groups:
GROUP A: Administration of Levosimendan at a dosage of 3mcg/kg after anesthesia induction.
GROUP B: Administration of Levosimendan at a dosage of 6mcg/kg after anesthesia induction.
GROUP C: Administration of Levosimendan at a dosage of 12mcg/kg after anesthesia induction.
Before and after the administration of the drug, heart function will be evaluated by hemodynamic measurements obtained by the Swan-Ganz catheter. These parameters will be heart rate (HR), blood pressure (BP), mean pulmonary arterial pressure (MPAP), central venous pressure (CVP), cardiac output (CO), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR). Transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE) will also be used. The anti-inflammatory action of Levosimendan will also be evaluated by interleukin-6 (IL-6) measurements.
This study will lead to conclusions regarding the effectiveness of Levosimendan administration in the treatment of right heart failure and PH in cardiac surgery patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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levosimendan administration at a dose of 3 mcg/kg after anesthesia induction
levosimendan will be administered at a dose of 3 mcg/kg after anesthesia induction
levosimendan at a dose of 3 mcg/kg
levosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction
levosimendan administration at a dose of 6 mcg/kg after anesthesia induction
levosimendan will be administered at a dose of 6 mcg/kg after anesthesia induction
levosimendan at a dose of 6 mcg/kg
levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
levosimendan administration at a dose of 12 mcg/kg after anesthesia induction
levosimendan will be administered at a dose of 12 mcg/kg after anesthesia induction
levosimendan at a dose of 12 mcg/kg
levosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction
Interventions
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levosimendan at a dose of 3 mcg/kg
levosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction
levosimendan at a dose of 6 mcg/kg
levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
levosimendan at a dose of 12 mcg/kg
levosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction
Eligibility Criteria
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Inclusion Criteria
* elective cardiac surgery
Exclusion Criteria
* thromboembolic disease
* chronic obstructive pulmonary disease
* emergency surgery
* redo surgery
* inability to consent to the study
18 Years
75 Years
ALL
No
Sponsors
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Aretaieion University Hospital
OTHER
Responsible Party
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Dr Kassiani Theodoraki
Professor of Anesthesiology
Principal Investigators
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Kassiani Theodoraki, PhD, DESA
Role: PRINCIPAL_INVESTIGATOR
Aretaieion University Hospital
Locations
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Onassis Cardiac Surgery Center
Athens, , Greece
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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annie-panagiotis
Identifier Type: -
Identifier Source: org_study_id
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