Cardiac Surgery, Cardiopulmonary Bypass, Congenital Heart Defects
Conditions
Keywords
Pediatric cardiac surgery, Dexamethasone, Steroids, Cardiopulmonary bypass, Congenital heart defects, Infants
Brief summary
Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.
Interventions
DRUGDexamethasone
DRUGPlacebo
0.9% Sodium Chloride
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
Inclusion criteria
* elective repair of congenital heart defects under cardiopulmonary bypass
Exclusion criteria
* absence of written informed consent signed by parent or guardian; * hypoplastic left heart syndrome; * participation in conflicting randomised studies; * emergency surgery; * inotropic support prior to surgery; * mechanical ventilation prior to surgery; * bacterial, viral or fungal infection in the preceding 30 days; * gestational age less that 37 weeks; * perinatal central nervous system damage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major complications | 30 days after surgery | Composite of all-cause death, myocardial infarction, need for extracorporeal membrane oxygenation implantation, cardiac arrest, acute renal failure (stage injury or higher according to pRIFLE scale), prolonged mechanical ventilation (\> 24 hours), stroke, seizure, coma. |
Countries
Brazil, China, Russia
Outcome results
None listed