Levosimendan and Myocardial Protection

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: Myocardial Protection

Treatments: Drug: Placebo; Drug: levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT00610350

LV 2003

LV-2003-01

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

L

Experimental group

Treatment:

Drug: levosimendan

P

Experimental group

Treatment:

Drug: Placebo