Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
NCT ID: NCT05927233
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2023-04-01
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group M
IV Methylprednisolone
Methylprednisolone
30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg
Group P
IV Normal Saline
Saline
30 ml Normal saline
Interventions
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Methylprednisolone
30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg
Saline
30 ml Normal saline
Eligibility Criteria
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Inclusion Criteria
* Undergoing Cardiac surgery for the first time and requiring CPB
* Surgeries for both cyatonic and acyanotic heart disease
Exclusion Criteria
* 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
1 Month
18 Years
ALL
No
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Dr. Muhammad Saad Yousuf
Senior Instructor
Locations
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Aga Khan University Hospital
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2021-6247-18639
Identifier Type: -
Identifier Source: org_study_id
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