Congenital Cardiovascular Defects, Low Cardiac Output Syndrome
Conditions
Keywords
cardiac surgery with cardiopulmonary bypass
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.
Interventions
DRUGLevosimendan
Intravenous injection
DRUGMilrinone
Intravenous injection
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum lactate | 12 h postoperatively |
Countries
Belgium
Outcome results
None listed