Intraoperative Dexamethasone in Pediatric Cardiac Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Congenital Heart Defects
• Intervention / Treatment: Drug: Dexamethasone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 394
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • San Paolo, Brazil
    • Dante Pazzanese Cardiology Institute
• China
  • Shanghai, China
    • Shanghai Childrens Medical Center
• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Novosibirsk research institute of circulation pathology
  • Penza, Russian Federation
    • Federal Center of Cardiovascular Surgery, Penza city

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Dexamethasone 1 mg per 1 kg of body weight intravenously immediately after induction of anesthesia	Drug: Dexamethasone
Placebo Comparator: Control; 0.9% Sodium Chloride 0.25 ml per 1 kg of body weight intravenously immediately after induction of anesthesia	Drug: Placebo; 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complications	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.	30 days after surgery

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Principal Investigator: Vladimir Lomivorotov, PhD, Novosibirsk research institute of circulation pathology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Dexamethasone; Infants; Cardiopulmonary bypass; Steroids; Congenital heart defects; Pediatric cardiac surgery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: Dex01