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NCT Number: NCT05927233

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

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).

Recruiting

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location status: Recruiting

Location contact

Khalid Samad, FCPS

SUB_INVESTIGATOR

Khalid Siddiqui, FCPS

SUB_INVESTIGATOR

Muhammad Saad Yousuf, FCPS

PRINCIPAL_INVESTIGATOR

Muhammad Saad Yousuf, MBBS, FCPS

CONTACT

[email protected]

00923003540362

Syed Shabir Ahmed, FCPS

SUB_INVESTIGATOR

Waris Ahmed, FRCS

SUB_INVESTIGATOR

mohammad Hamid, FCPS

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

Saline

Drug

30 ml Normal saline

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Saad Yousuf, MBBS, FCPS

CONTACT

[email protected]

+923003540362

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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