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Levosimendan and Myocardial Protection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610350
First Posted: February 7, 2008
Last Update Posted: February 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University College London Hospitals
Information provided by:
University of Roma La Sapienza
January 24, 2008
February 7, 2008
February 7, 2008
January 2005
February 2007   (Final data collection date for primary outcome measure)
Length of ICU stay [ Time Frame: two weeks ]
Same as current
No Changes Posted
  • Length of hospital stay [ Time Frame: 3 weeks ]
  • Tracheal intubation time [ Time Frame: one week ]
  • Inotropic support over the first 7 days [ Time Frame: one week ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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. doi: 10.1093/bja/aen367.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00610350
LV 2003
LV-2003-01
No
Not Provided
Not Provided
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