Actively Recruiting
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
Led by Aga Khan University · Updated on 2024-07-31
60
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children 1 month to 18 years of age
- Undergoing cardiac surgery for the first time requiring cardiopulmonary bypass
- Surgeries for both cyanotic and acyanotic heart disease
You will not qualify if you...
- Premature babies born before 28 weeks gestation
- Neonates
- Prior cardiac surgery requiring cardiopulmonary bypass
- Surgeries requiring cardiopulmonary bypass longer than 6 hours
- Surgeries requiring a second run of cardiopulmonary bypass
- Patients needing additional steroids during the first 24 hours after surgery
- Patients who die within the initial 24 hours after surgery
- Known immune system problems or use of immunomodulatory therapy
- Presence of two or more signs of active infection before surgery, such as fever over 100°F, high heart or breathing rate, high white blood cell count, or elevated C-reactive protein
- Preoperative mechanical ventilation or need for inotropic agents or mechanical circulatory support
- Patients already receiving steroids
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Actively Recruiting
Research Team
M
Muhammad Saad Yousuf, MBBS, FCPS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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