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Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
RECRUITINGPhase 4Sponsored by Aga Khan University
Actively Recruiting
PhasePhase 4
SponsorAga Khan University
Started2023-04-01
Est. completion2025-04-30
Eligibility
Age1 Month – 18 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05927233
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
Age: 1 Month – 18 YearsHealthy volunteers accepted
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
Conditions3
Cardiopulmonary BypassCyanotic Heart DiseaseHeart Disease
Interventions1
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Actively Recruiting
PhasePhase 4
SponsorAga Khan University
Started2023-04-01
Est. completion2025-04-30
Eligibility
Age1 Month – 18 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05927233