Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT02615262

Collaborator

(none)

394

Enrollment

Locations

Arms

Actual Duration (Months)

98.5

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Congenital Heart Defects Cardiopulmonary Bypass	Drug: Dexamethasone Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

394 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Major complications [30 days after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Months

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Dante Pazzanese Cardiology Institute	San Paolo	Brazil
2	Shanghai Childrens Medical Center	Shanghai	China
3	Novosibirsk Research Institute of Circulation Pathology	Novosibirsk	Russian Federation	630055
4	Federal Center of Cardiovascular Surgery, Penza city	Penza	Russian Federation