Clinical trial NCT02615262: Intraoperative Dexamethasone in Pediatric Cardiac Surgery
Official title: Intraoperative Dexamethasone in Pediatric Cardiac Surgery: a Prospective Double-blind Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Congenital Heart Defects
Cardiopulmonary Bypass
Keywords: Pediatric cardiac surgery
Dexamethasone
Steroids
Cardiopulmonary bypass
Congenital heart defects
Infants
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-11-26
Enrollment: 394
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major complications
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Paolo
country: Brazil
facility: Dante Pazzanese Cardiology Institute
city: Shanghai
country: China
facility: Shanghai Childrens Medical Center
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Circulation Pathology
city: Penza
country: Russian Federation
facility: Federal Center of Cardiovascular Surgery, Penza city
Study officials:
affiliation: Novosibirsk Research Institute of Circulation Pathology
name: Vladimir Lomivorotov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.
citation: Lomivorotov V, Kornilov I, Boboshko V, Shmyrev V, Bondarenko I, Soynov I, Voytov A, Polyanskih S, Strunin O, Bogachev-Prokophiev A, Landoni G, Nigro Neto C, Oliveira Nicolau G, Saurith Izquierdo L, Nogueira Nascimento V, Wen Z, Renjie H, Haibo Z, Bazylev V, Evdokimov M, Sulejmanov S, Chernogrivov A, Ponomarev D. Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial. JAMA. 2020 Jun 23;323(24):2485-2492. doi: 10.1001/jama.2020.8133.