NCT05927233

Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery

Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cyanotic Heart Disease
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
DRUG	Methylprednisolone	30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg
DRUG	Saline	30 ml Normal saline

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2023-07-03
• Last updated: 2024-07-31

Locations

1 site across 1 country: Pakistan