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

Sponsor

Aga Khan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05927233

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cyanotic Heart Disease Cardiopulmonary Bypass	Drug: Methylprednisolone Drug: Saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Feb 28, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group M IV Methylprednisolone	Drug: Methylprednisolone 30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg
Placebo Comparator: Group P IV Normal Saline	Drug: Saline 30 ml Normal saline

Arm

Intervention/Treatment

Experimental: Group M

IV Methylprednisolone

Drug: Methylprednisolone

30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg

Placebo Comparator: Group P

IV Normal Saline

Drug: Saline

30 ml Normal saline

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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