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

Launched by AGA KHAN UNIVERSITY · Jun 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a steroid called methylprednisolone on inflammation in children who are having heart surgery. Specifically, it looks at how this steroid might help reduce the body’s inflammatory response after surgery for congenital heart diseases, which are conditions present at birth that affect the heart's structure. The surgery involves a procedure called cardiopulmonary bypass (CPB), where a machine temporarily takes over the job of the heart and lungs during the operation.

To participate in this study, children aged 1 month to 18 years who are having their first heart surgery requiring CPB may be eligible. However, some children cannot participate, including premature babies, those with certain infections or immune system issues, and those who have had previous heart surgeries. If enrolled, participants will receive the steroid during their surgery and researchers will monitor their recovery and response over the following days. This study aims to improve the care and outcomes for young patients undergoing heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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