The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery

Summary

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.

Conditions

• Heart Valve Disease

Interventions

DRUG

levosimendan

12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min

DRUG

placebo

nacl 0.9% coloured with thiamin in same volume and time than levosimendan

Sponsors & Collaborators

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Heli Leppikangas, MD · Department of Anaesthesia, Tampere UH

• Kati Järvelä, MD,PhD · Heart Center, Pirkanmaa Hospital District

• Tero Sisto, MD, PhD · Heart Center, Pirkanmaa Hospital District

• Pasi Maaranen, MD · Heart Center, Pirkanmaa Hospitla District

• Pasi Lehto, MD,PhD · Heart Center, Pirkanmaa Hospital District

• Marko Virtanen, MD,PhD · Heart Center, Pirkanmaa Hospital District

• Sari Karlsson, MD · Department of Intensive Care, Tampere UH

• Esko Ruokonen, MD,PhD · Department of Intensive Care, Kuopio UH

• Leena Lindgren, MD,PhD · Department of Anaesthesia, Tampere UH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2010-09-30

Completion

2010-09-30

Countries

• Finland

Study Locations