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Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR) together with coronary artery bypass grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will be carried out in Heart Center.
Twenty four patients will be randomized into two groups of 12. The treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn, Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. Echo cardiography will be done pre- and postoperatively. Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levosimendan | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levosimendan | Drug | 12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min |
| |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| echocardiography | baseline, 1st and 5th postoperative day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heli Leppikangas, MD | Department of Anaesthesia, Tampere UH | Principal Investigator |
| Kati Järvelä, MD,PhD | Heart Center, Pirkanmaa Hospital District | Study Chair |
| Tero Sisto, MD, PhD | Heart Center, Pirkanmaa Hospital District | Study Chair |
| Pasi Maaranen, MD | Heart Center, Pirkanmaa Hospitla District | Study Chair |
| Pasi Lehto, MD,PhD | Heart Center, Pirkanmaa Hospital District | Study Chair |
| Marko Virtanen, MD,PhD | Heart Center, Pirkanmaa Hospital District | Study Chair |
| Sari Karlsson, MD | Department of Intensive Care, Tampere UH | Study Chair |
| Esko Ruokonen, MD,PhD | Department of Intensive Care, Kuopio UH | Study Chair |
| Leena Lindgren, MD,PhD | Department of Anaesthesia, Tampere UH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21258075 | Derived | Leppikangas H, Jarvela K, Sisto T, Maaranen P, Virtanen M, Lehto P, Karlsson S, Koobi T, Lindgren L. Preoperative levosimendan infusion in combined aortic valve and coronary bypass surgery. Br J Anaesth. 2011 Mar;106(3):298-304. doi: 10.1093/bja/aeq402. Epub 2011 Jan 21. |
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| placebo |
| Drug |
nacl 0.9% coloured with thiamin in same volume and time than levosimendan |
|
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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