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

September 20, 2011 updated by: Tampere University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • allergy to levosimendan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
nacl 0.9% coloured with thiamin in same volume and time than levosimendan
Experimental: levosimendan
Drug: levosimendan
12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: up to 5 days
up to 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
echocardiography
Time Frame: baseline, 1st and 5th postoperative day
baseline, 1st and 5th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Heli Leppikangas, MD, Department of Anaesthesia, Tampere UH
  • Study Chair: 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 Director: Leena Lindgren, MD,PhD, Department of Anaesthesia, Tampere UH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R08039M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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