Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Meshalkin Research Institute of Pathology of Circulation394 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

394

Conditions

Cardiac Surgery Congenital Heart Defects Cardiopulmonary Bypass

Interventions

Eligibility

Sex: ALLMax age: 12 Months

Medical Language ↔ Plain English

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.

Locations (4)

Dante Pazzanese Cardiology Institute

São Paulo, Brazil

Shanghai Childrens Medical Center

Shanghai, China

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, Russia

Federal Center of Cardiovascular Surgery, Penza city

Penza, Russia

Outcomes

Primary Outcomes

Major complications

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.

Time frame: 30 days after surgery