Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Phase 3

Completed

• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Congenital Heart Defects
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT02615262
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Study Start: 2015-12
• Primary Completion: 2018-11
• Status Verified: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	0.9% Sodium Chloride 0.25 ml per 1 kg of body weight intravenously immediately after induction of anesthesia
Experimental	Dexamethasone	Dexamethasone 1 mg per 1 kg of body weight intravenously immediately after induction of anesthesia

Primary Outcome Measures

Name	Time	Method
Major complications	30 days after surgery	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.

Trial Locations

Locations (4)

Dante Pazzanese Cardiology Institute; 🇧🇷 San Paolo, Brazil

Shanghai Childrens Medical Center; 🇨🇳 Shanghai, China

Novosibirsk Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation

Federal Center of Cardiovascular Surgery, Penza city; 🇷🇺 Penza, Russian Federation