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

Phase 4

Recruiting

• Conditions: Cyanotic Heart Disease; Cardiopulmonary Bypass
• Interventions: Drug: Saline; Drug: Methylprednisolone

• Registration Number: NCT05927233
• Lead Sponsor: Aga Khan University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Saline	IV Normal Saline
Group M	Methylprednisolone	IV Methylprednisolone

Primary Outcome Measures

Name	Time	Method
Serum levels of Interleukin- 6	Before the first dose of steroid), second sample will be drawn after immediately protamine infusion, third sample at 24 hours after CPB and the fourth sample will be drawn at 48 hours after CPB	serum levels of Interleukin- 6 will be measured using ELISA
Serum levels of CRP	Before the first dose of steroid), second sample will be drawn after immediately protamine infusion, third sample at 24 hours after CPB and the fourth sample will be drawn at 48 hours after CPB	serum levels of CRP will be measured using ELISA

Secondary Outcome Measures

Name	Time	Method
Serum creatinine level	Before the first dose of steroid), second sample will be drawn after immediately protamine infusion, third sample at 24 hours after CPB and the fourth sample will be drawn at 48 hours after CPB

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sindh, Pakistan