NCT01595737

Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF \< 35%.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	Levosimendan	Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.
DRUG	Placebo	Placebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min.

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-05-10
• Last updated: 2015-03-12

Locations

1 site across 1 country: Spain