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RecruitingNCT05927233Updated Jul 31, 2024

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

A Phase 4 interventional study of Methylprednisolone and Saline in Cyanotic Heart Disease and Cardiopulmonary Bypass, sponsored by Aga Khan University. Recruiting at 1 site in Pakistan. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Aga Khan University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Month to 18 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Cyanotic Heart Disease
  • Cardiopulmonary Bypass

Browse trials for

Keywords

  • Paediatric population
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group M

    IV Methylprednisolone

    Drug: Methylprednisolone

  • Placebo comparator
    Group P

    IV Normal Saline

    Drug: Saline

Interventions

  • DrugMethylprednisolone

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

  • DrugSaline

    30 ml Normal saline

06

What researchers measure

Primary outcomes

  1. Serum levels of Interleukin- 6

    serum levels of Interleukin- 6 will be measured using ELISA

    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

  2. Serum levels of CRP

    serum levels of CRP will be measured using ELISA

    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

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

07

Study locations

1 of 1 sites recruiting
  • Aga Khan University Hospital
    Karachi, Sindh 74800, Pakistan
    • Muhammad Saad Yousuf, MBBS, FCPS · Contact · saad.yousuf@aku.edu · 00923003540362
    • mohammad Hamid, FCPS · Sub investigator
    • Syed Shabir Ahmed, FCPS · Sub investigator
    • Waris Ahmed, FRCS · Sub investigator
    • Khalid Samad, FCPS · Sub investigator
    • Khalid Siddiqui, FCPS · Sub investigator
    • Muhammad Saad Yousuf, FCPS · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23602068 ↗
  • 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. PubMed 33045104 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05927233
Lead sponsor
Aga Khan University
Responsible party
Dr. Muhammad Saad Yousuf (Senior Instructor, Aga Khan University) — Principal investigator
First posted
Jul 3, 2023
Start date
Apr 1, 2023
Primary completion
Apr 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jul 31, 2024

Study contacts

Muhammad Saad Yousuf, MBBS, FCPS
Contact
saad.yousuf@aku.edu
+923003540362

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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