Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Cardiac Surgery Clinical Trial

Official title:

Intraoperative Dexamethasone in Pediatric Cardiac Surgery: a Prospective Double-blind Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615262
• Other study ID #: Dex01
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass
• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

Drug:
• Dexamethasone

• Placebo
0.9% Sodium Chloride

Locations

Country	Name	City	State
Brazil	Dante Pazzanese Cardiology Institute	San Paolo
China	Shanghai Childrens Medical Center	Shanghai
Russian Federation	Novosibirsk Research Institute of Circulation Pathology	Novosibirsk
Russian Federation	Federal Center of Cardiovascular Surgery, Penza city	Penza

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Countries where clinical trial is conducted

Brazil,  China,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days after surgery