NCT05927233

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

June 22, 2023

Last Update Submit

July 30, 2024

Conditions

Cyanotic Heart DiseaseCardiopulmonary Bypass

Keywords

Paediatric population

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Group M

EXPERIMENTAL

IV Methylprednisolone

Drug: Methylprednisolone

Group P

PLACEBO COMPARATOR

IV Normal Saline

Drug: Saline

Interventions

MethylprednisoloneDRUG

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

Group M
SalineDRUG

30 ml Normal saline

Group P

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23602068BACKGROUND

  • 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.

    PMID: 33045104BACKGROUND

MeSH Terms

Interventions

MethylprednisoloneSodium Chloride

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Muhammad Saad Yousuf, MBBS, FCPS

CONTACT

+923003540362saad.yousuf@aku.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 3, 2023

Study Start

April 1, 2023

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)