NCT02615262

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
394

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

2.9 years

First QC Date

November 23, 2015

Last Update Submit

December 19, 2018

Conditions

Cardiac SurgeryCongenital Heart DefectsCardiopulmonary Bypass

Keywords

Pediatric cardiac surgeryDexamethasoneSteroidsCardiopulmonary bypassCongenital heart defectsInfants

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

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

Drug: Dexamethasone

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DexamethasoneDRUG
Experimental
PlaceboDRUG

0.9% Sodium Chloride

Control

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • elective repair of congenital heart defects under cardiopulmonary bypass

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dante Pazzanese Cardiology Institute

São Paulo, Brazil

Location

Shanghai Childrens Medical Center

Shanghai, China

Location

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Federal Center of Cardiovascular Surgery, Penza city

Penza, Russia

Location

Related Publications (2)

  • 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.

    PMID: 33045104DERIVED

  • 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.

    PMID: 32573670DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Vladimir Lomivorotov, PhD

    Novosibirsk Research Institute of Circulation Pathology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 26, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Locations

BR(1)RU(2)CN(1)