RecruitingPhase 4NCT05927233

Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery

Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial

Sponsor

Aga Khan University

Enrollment

60 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Cyanotic Heart Disease Cardiopulmonary Bypass

Summary

The goal of this study is to evaluate the effects of steroids on the early postoperative inflammatory response in patients undergoing elective pediatric congenital cardiac surgery, requiring cardiopulmonary bypass (CPB).

Eligibility

Min Age: 1 MonthMax Age: 18 Years

Inclusion Criteria3

Children 1 month- 18 years of age
Undergoing Cardiac surgery for the first time and requiring CPB
Surgeries for both cyatonic and acyanotic heart disease

Exclusion Criteria12

Pre-mature babies (< 28 weeks at birth)
Neonates
Prior cardiac requiring CPB
Surgeries requiring CPB > 6 hours
Surgeries requiring second run of CPB
Patients requiring additional steroids during first 24 hours of CICU stay
Patient expires within the initial 24 hours CICU stay.
Compromised immune system - that is, known immunodeficiency or use of
immunomodulatory therapy.
Peri-operative presence of two or more clinical or laboratory signs of active infection that were not attributable to any other cause: fever more than 100°F, heart rate or respiratory rate more than the normal range for age, white blood cell count more than 15% of the upper limit of normal, and an elevated C-reactive protein level above baseline.
Preoperative mechanical ventilation, and preoperative need of inotropic agents or mechanical circulatory support.
Patient already receiving steroids