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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
  Purpose
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.

Condition Intervention Phase
Myocardial Protection Drug: levosimendan Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Length of ICU stay [ Time Frame: two weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: January 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L 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
Experimental: P 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610350


Locations
Italy
University of Rome "Sapienza"
Rome, Italy, 00155
Sponsors and Collaborators
University of Roma La Sapienza
University College London Hospitals
Investigators
Principal Investigator: Vincenzo De Santis, M.D. University of Roma La Sapienza
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vincenzo De Santis, University of Rome "Sapienza"
ClinicalTrials.gov Identifier: NCT00610350     History of Changes
Other Study ID Numbers: LV 2003
LV-2003-01
First Submitted: January 24, 2008
First Posted: February 7, 2008
Last Update Posted: February 7, 2008
Last Verified: January 2008

Keywords provided by University of Roma La Sapienza:
Levosimendan
pre-conditioning
cardiac surgery
myocardial function
contractility
heart
ischaemia

Additional relevant MeSH terms:
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs