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Completed

NCT Number: NCT00610350

Levosimendan and Myocardial Protection

The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.

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Key information

Conditions

Myocardial Protection Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Rome "Sapienza"

Rome, 00155, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years
  • intention to perform first-time multi-vessel CABG

Exclusion criteria

  • unstable angina
  • valvular disease
  • diabetes mellitus treated with sulphonylurea drugs
  • renal failure
  • severe hepatic disease
  • severe chronic obstructive pulmonary disease
  • a history of prior CABG surgery
  • recent myocardial infarction (MI) within the previous month

Treatment and study plan

Levosimendan

Drug

24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB

Placebo

Drug

an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB

Primary outcomes

  1. Length of ICU stay

    Time frame: two weeks

Secondary outcomes

  1. Length of hospital stay

    Time frame: 3 weeks

  2. Tracheal intubation time

    Time frame: one week

  3. Inotropic support over the first 7 days

    Time frame: one week

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • University College London Hospitals

Registry information

Official study title

Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 7, 2008
Registry last updated
Feb 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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