Actively Recruiting

Phase 4
Age: 1Month - 18Years
All Genders
NCT05927233

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

Led by Aga Khan University · Updated on 2024-07-31

60

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Month - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children 1 month to 18 years of age
  • Undergoing cardiac surgery for the first time requiring cardiopulmonary bypass
  • Surgeries for both cyanotic and acyanotic heart disease
Not Eligible

You will not qualify if you...

  • Premature babies born before 28 weeks gestation
  • Neonates
  • Prior cardiac surgery requiring cardiopulmonary bypass
  • Surgeries requiring cardiopulmonary bypass longer than 6 hours
  • Surgeries requiring a second run of cardiopulmonary bypass
  • Patients needing additional steroids during the first 24 hours after surgery
  • Patients who die within the initial 24 hours after surgery
  • Known immune system problems or use of immunomodulatory therapy
  • Presence of two or more signs of active infection before surgery, such as fever over 100°F, high heart or breathing rate, high white blood cell count, or elevated C-reactive protein
  • Preoperative mechanical ventilation or need for inotropic agents or mechanical circulatory support
  • Patients already receiving steroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aga Khan University Hospital

Karachi, Sindh, Pakistan, 74800

Actively Recruiting

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Research Team

M

Muhammad Saad Yousuf, MBBS, FCPS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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