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

Recruiting
1 - 18 years of age
Both
Phase 4

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Overview

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

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

Study details

Cyanotic Heart Disease, Cardiopulmonary Bypass

NCT05927233

Aga Khan University

26 January 2024

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