drugset / Trial / NCT02615262

Intraoperative Dexamethasone in Pediatric Cardiac Surgery

NCT02615262 ↗

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2015-12
Primary completion
2018-11
Completion
2018-12

Outcome

Missed primary endpoint

paper hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P = .20). PMID 32573670 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 1 mg/kg Intravenous