NCT00695929

Levosimendan in Congenital Cardiac Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 1 Day – 5 Years
• Healthy volunteers: Not accepted

Summary

Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. Milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with calcium-sensitizing properties. We hypothesized that using Levosimendan would result in reduced serum lactate through a higher cardiac index.

Conditions

• Congenital Cardiovascular Defects
• Low Cardiac Output Syndrome

Interventions

Type	Name	Description
DRUG	Levosimendan	Intravenous injection
DRUG	Milrinone	Intravenous injection

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-09-01
• Completion: 2009-10-01
• First posted: 2008-06-12
• Last updated: 2010-01-26

Locations

1 site across 1 country: Belgium