Intraoperative Dexamethasone in Pediatric Cardiac Surgery

M

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

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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