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Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Primary Purpose

Cardiac Surgery, Congenital Heart Defects, Cardiopulmonary Bypass

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery focused on measuring Pediatric cardiac surgery, Dexamethasone, Steroids, Cardiopulmonary bypass, Congenital heart defects, Infants

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • Dante Pazzanese Cardiology Institute
  • Shanghai Childrens Medical Center
  • Novosibirsk Research Institute of Circulation Pathology
  • Federal Center of Cardiovascular Surgery, Penza city

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2015
Last Updated
December 19, 2018
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02615262
Brief Title
Intraoperative Dexamethasone in Pediatric Cardiac Surgery
Official Title
Intraoperative Dexamethasone in Pediatric Cardiac Surgery: a Prospective Double-blind Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Congenital Heart Defects, Cardiopulmonary Bypass
Keywords
Pediatric cardiac surgery, Dexamethasone, Steroids, Cardiopulmonary bypass, Congenital heart defects, Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Dexamethasone 1 mg per 1 kg of body weight intravenously immediately after induction of anesthesia
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
0.9% Sodium Chloride 0.25 ml per 1 kg of body weight intravenously immediately after induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% Sodium Chloride
Primary Outcome Measure Information:
Title
Major complications
Description
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.
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Lomivorotov, PhD
Organizational Affiliation
Novosibirsk Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dante Pazzanese Cardiology Institute
City
San Paolo
Country
Brazil
Facility Name
Shanghai Childrens Medical Center
City
Shanghai
Country
China
Facility Name
Novosibirsk Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Federal Center of Cardiovascular Surgery, Penza city
City
Penza
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
33045104
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.
Results Reference
derived
PubMed Identifier
32573670
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.
Results Reference
derived

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Intraoperative Dexamethasone in Pediatric Cardiac Surgery

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