Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 3

Conditions: Cardiac Surgery; Congenital Heart Defects; Cardiopulmonary Bypass

Treatments: Drug: Placebo; Drug: Dexamethasone

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02615262

Dex01

Details and patient eligibility

About

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.

Enrollment: 394 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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394 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Dexamethasone 1 mg per 1 kg of body weight intravenously immediately after induction of anesthesia

Treatment:

Drug: Dexamethasone

Control

Placebo Comparator group

Description:

0.9% Sodium Chloride 0.25 ml per 1 kg of body weight intravenously immediately after induction of anesthesia

Treatment:

Drug: Placebo