Levosimendan and Myocardial Protection

Myocardial Protection Clinical Trial

Official title:

Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610350
• Other study ID #: LV 2003
• Secondary ID: LV-2003-01
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2008
• Last updated: February 6, 2008
• Start date: January 2005
• Est. completion date: February 2007

Study information

• Verified date: January 2008
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Protection

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	University of Rome "Sapienza"	Rome

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	University College London Hospitals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of ICU stay		two weeks	No
Secondary	Length of hospital stay		3 weeks	No
Secondary	Tracheal intubation time		one week	No
Secondary	Inotropic support over the first 7 days		one week	No