Intraoperative Dexamethasone in Pediatric Cardiac Surgery

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.