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

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927233
• Other study ID #: 2021-6247-18639
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2023
• Source: Aga Khan University
• Contact: Muhammad Saad Yousuf, MBBS, FCPS
• Phone: +923003540362
• Email: saad.yousuf[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Cyanotic Heart Disease
• Heart Diseases

Intervention

Drug:
• Methylprednisolone
30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg
• Saline
30 ml Normal saline

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2. — View Citation

Keski-Nisula J, Pesonen E, Olkkola KT, Peltola K, Neuvonen PJ, Tuominen N, Sairanen H, Andersson S, Suominen PK. Methylprednisolone in neonatal cardiac surgery: reduced inflammation without improved clinical outcome. Ann Thorac Surg. 2013 Jun;95(6):2126-32. doi: 10.1016/j.athoracsur.2013.02.013. Epub 2013 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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