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

Aga Khan University

Status and phase: Enrolling; Phase 4

Conditions: Cyanotic Heart Disease; Cardiopulmonary Bypass

Treatments: Drug: Saline; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05927233

2021-6247-18639

Details and patient eligibility

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Group M

Experimental group

Description:

IV Methylprednisolone

Treatment:

Drug: Methylprednisolone

Group P

Placebo Comparator group

Description:

IV Normal Saline

Treatment:

Drug: Saline