Trials / Completed
CompletedNCT02615262
Intraoperative Dexamethasone in Pediatric Cardiac Surgery
Intraoperative Dexamethasone in Pediatric Cardiac Surgery: a Prospective Double-blind Randomised Clinical Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 394 (actual)
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation · Network
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone | |
| DRUG | Placebo | 0.9% Sodium Chloride |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2018-11-01
- Completion
- 2018-12-01
- First posted
- 2015-11-26
- Last updated
- 2018-12-21
Locations
4 sites across 3 countries: Brazil, China, Russia
Source: ClinicalTrials.gov record NCT02615262. Inclusion in this directory is not an endorsement.