Levosimendan and Myocardial Protection - Full Text View

Sponsors and Collaborators:	University of Roma La Sapienza University College London Hospitals
Information provided by:	University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT00610350

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 IV

Drug Information available for: Levosimendan Simendan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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
L: Experimental	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
P: Experimental	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

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 Rome "Sapienza"

More Information

Responsible Party:	University of Rome "Sapienza" ( Vincenzo De Santis )
Study ID Numbers:	LV 2003, LV-2003-01
Study First Received:	January 24, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00610350
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:

Levosimendan
pre-conditioning
cardiac surgery
myocardial function

contractility
heart
ischaemia

Study placed in the following topic categories:

Ischemia
Simendan

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Cardiovascular Agents
Anti-Arrhythmia Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009