Clinical trial NCT01210976: The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery
Official title: The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Valve Disease
Keywords: levosimendan
CABG
AVR
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* allergy to levosimendan

Primary outcomes:
measure: blood pressure
timeFrame: up to 5 days
Secondary outcomes:
measure: echocardiography
timeFrame: baseline, 1st and 5th postoperative day
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Department of Anaesthesia, Tampere UH
name: Heli Leppikangas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center, Pirkanmaa Hospital District
name: Kati Järvelä, MD,PhD
role: STUDY_CHAIR
affiliation: Heart Center, Pirkanmaa Hospital District
name: Tero Sisto, MD, PhD
role: STUDY_CHAIR
affiliation: Heart Center, Pirkanmaa Hospitla District
name: Pasi Maaranen, MD
role: STUDY_CHAIR
affiliation: Heart Center, Pirkanmaa Hospital District
name: Pasi Lehto, MD,PhD
role: STUDY_CHAIR
affiliation: Heart Center, Pirkanmaa Hospital District
name: Marko Virtanen, MD,PhD
role: STUDY_CHAIR
affiliation: Department of Intensive Care, Tampere UH
name: Sari Karlsson, MD
role: STUDY_CHAIR
affiliation: Department of Intensive Care, Kuopio UH
name: Esko Ruokonen, MD,PhD
role: STUDY_CHAIR
affiliation: Department of Anaesthesia, Tampere UH
name: Leena Lindgren, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.