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

Phase 4

Completed

• Conditions: Heart Valve Disease
• Interventions: Drug: placebo; Drug: levosimendan

• Registration Number: NCT01210976
• Lead Sponsor: Tampere University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2010-09-24
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-20
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• LVEF less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm

Exclusion Criteria

• allergy to levosimendan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
levosimendan	levosimendan	-

Primary Outcome Measures

Name	Time	Method
blood pressure	up to 5 days

Secondary Outcome Measures

Name	Time	Method
echocardiography	baseline, 1st and 5th postoperative day

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland