Status:
RECRUITING
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
Lead Sponsor:
Aga Khan University
Conditions:
Cyanotic Heart Disease
Cardiopulmonary Bypass
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief 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 cardiopul...
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
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05927233
Start Date
April 1 2023
End Date
June 30 2025
Last Update
July 31 2024
Active Locations (1)
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1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800