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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Roma La Sapienza

Additional 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
Study First Received: January 24, 2008
Last Updated: February 6, 2008
Health Authority: Italy: Ethics Committee

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
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014