Levosimendan in Congenital Cardiac Surgery

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Low Cardiac Output Syndrome; Congenital Cardiovascular Defects

Treatments: Drug: Milrinone; Drug: Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT00695929

Levosimendan

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 day to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind