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Levosimendan and Myocardial Protection

This study has been completed.
Sponsor:
Collaborator:
University College London Hospitals
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00610350
First received: January 24, 2008
Last updated: February 6, 2008
Last verified: January 2008
History of Changes

January 24, 2008
February 6, 2008
January 2005
February 2007   (final data collection date for primary outcome measure)
Length of ICU stay [ Time Frame: two weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610350 on ClinicalTrials.gov Archive Site
  • Length of hospital stay [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Tracheal intubation time [ Time Frame: one week ] [ Designated as safety issue: No ]
  • Inotropic support over the first 7 days [ Time Frame: one week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Levosimendan and Myocardial Protection
Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Protection
  • Drug: levosimendan
    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
  • Drug: Placebo
    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
  • Experimental: L
    Intervention: Drug: levosimendan
  • Experimental: P
    Intervention: Drug: Placebo
Tritapepe L, De Santis V, Vitale D, Guarracino F, Pellegrini F, Pietropaoli P, Singer M. Levosimendan pre-treatment improves outcomes in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2009 Feb;102(2):198-204.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00610350
LV 2003, LV-2003-01
No
Vincenzo De Santis, University of Rome "Sapienza"
University of Roma La Sapienza
University College London Hospitals
Principal Investigator: Vincenzo De Santis, M.D. University of Roma La Sapienza
University of Roma La Sapienza
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP