NCT05927233 Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
| NCT ID | NCT05927233 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Aga Khan University |
| Condition | Cyanotic Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2023-04-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 cardiopulmonary bypass (CPB).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05927233 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Cyanotic Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05927233 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05927233 currently recruiting?
Yes, NCT05927233 is actively recruiting participants. Contact the research team at saad.yousuf@aku.edu for enrollment information.
Where is the NCT05927233 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT05927233 clinical trial?
NCT05927233 is sponsored by Aga Khan University. The trial plans to enroll 60 participants.