Effects of Methylprednisolone on Inflammation in Children After Heart Surgery
Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial
This study tests if giving a steroid called methylprednisolone can help reduce inflammation in children aged 1 month to 18 years after they have heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT05927233 on ClinicalTrials.gov |
What this trial studies
This study evaluates how methylprednisolone, a steroid, influences the inflammatory response in children undergoing elective congenital heart surgery that requires cardiopulmonary bypass. By comparing the effects of methylprednisolone to saline, the study aims to determine if steroid treatment can mitigate postoperative inflammation. The trial focuses on pediatric patients aged 1 month to 18 years who are having their first cardiac surgery. The outcomes will help understand the role of steroids in improving recovery after such surgeries.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 month to 18 years undergoing their first elective cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients with compromised immune systems or those requiring prolonged cardiopulmonary bypass may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and outcomes for children undergoing heart surgery.
How similar studies have performed: Other studies have shown promising results with steroid use in similar surgical contexts, suggesting potential benefits in managing inflammation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Karachi, Sindh
- Aga Khan University Hospital — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Study coordinator: Muhammad Saad Yousuf, MBBS, FCPS
- Email: saad.yousuf@aku.edu
- Phone: +923003540362
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.