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OpenTrials
Completed

NCT Number: NCT02615262

Intraoperative Dexamethasone in Pediatric Cardiac Surgery

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.

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Key information

Conditions

Cardiac Surgery Cardiopulmonary Bypass Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Defects Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dante Pazzanese Cardiology Institute, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

Placebo

Drug

0.9% Sodium Chloride

Primary outcomes

  1. Major complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2015
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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