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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cyanotic Heart Disease, Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of Interleukin- 6 | serum levels of Interleukin- 6 will be measured using ELISA | 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 | serum levels of CRP will be measured using ELISA | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paediatric population