Levosimendan and Myocardial Protection

Phase 4

Completed

• Conditions: Myocardial Protection
• Interventions: Drug: levosimendan; Drug: Placebo

• Registration Number: NCT00610350
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2008-01
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-06
• Last Update Submitted: 2008-02-06
• Study First Posted: 2008-02-07
• Last Update Posted: 2008-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age ≥18 years
• intention to perform first-time multi-vessel CABG

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L	levosimendan	-
P	Placebo	-

Primary Outcome Measures

Name	Time	Method
Length of ICU stay	two weeks

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	3 weeks
Tracheal intubation time	one week
Inotropic support over the first 7 days	one week

Trial Locations

Locations (1)

University of Rome "Sapienza"; 🇮🇹 Rome, Italy