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Intraoperative Dexamethasone in Pediatric Cardiac Surgery

NCT ID: NCT02615262

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgery Congenital Heart Defects Cardiopulmonary Bypass

Keywords

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Pediatric cardiac surgery Dexamethasone Steroids Cardiopulmonary bypass Congenital heart defects Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% Sodium Chloride

Interventions

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Dexamethasone

Intervention Type DRUG

Placebo

0.9% Sodium Chloride

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir Lomivorotov, PhD

Role: PRINCIPAL_INVESTIGATOR

Novosibirsk Research Institute of Circulation Pathology

Locations

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Dante Pazzanese Cardiology Institute

São Paulo, , Brazil

Site Status

Shanghai Childrens Medical Center

Shanghai, , China

Site Status

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Federal Center of Cardiovascular Surgery, Penza city

Penza, , Russia

Site Status

Countries

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Brazil China Russia

References

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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.

Reference Type DERIVED
PMID: 33045104 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32573670 (View on PubMed)

Other Identifiers

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Dex01

Identifier Type: -

Identifier Source: org_study_id