Heart Valve Disease Clinical Trial
Official title:
The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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