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

July 30, 2024 updated by: Dr. Muhammad Saad Yousuf, Aga Khan University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Muhammad Saad Yousuf, MBBS, FCPS
  • Phone Number: +923003540362
  • Email: saad.yousuf@aku.edu

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Recruiting
        • Aga Khan University Hospital
        • Contact:
        • Sub-Investigator:
          • mohammad Hamid, FCPS
        • Sub-Investigator:
          • Syed Shabir Ahmed, FCPS
        • Sub-Investigator:
          • Waris Ahmed, FRCS
        • Sub-Investigator:
          • Khalid Samad, FCPS
        • Sub-Investigator:
          • Khalid Siddiqui, FCPS
        • Principal Investigator:
          • Muhammad Saad Yousuf, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of Interleukin- 6
Time Frame: 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
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
Time Frame: 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
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
Time Frame
Serum creatinine level
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-6247-18639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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