Levosimendan in Congenital Cardiac Surgery

Not Applicable

Completed

• Conditions: Congenital Cardiovascular Defects; Low Cardiac Output Syndrome

• Registration Number: NCT00695929
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Study Start: 2008-07
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support

Exclusion Criteria

• Patients with renal and/or hepatic dysfunction
• Patients requiring inotropic support before their surgery
• Septic patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
serum lactate	12 h postoperatively

Trial Locations

Locations (1)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium