Back to resultsEffect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
Primary Purpose
Cyanotic Heart Disease, Cardiopulmonary Bypass
Status
Recruiting
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Methylprednisolone
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Cyanotic Heart Disease focused on measuring Paediatric population
Eligibility Criteria
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
Sites / Locations
- Aga Khan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group M
Group P
Arm Description
IV Methylprednisolone
IV Normal Saline
Outcomes
Primary Outcome Measures
Serum levels of Interleukin- 6
serum levels of Interleukin- 6 will be measured using ELISA
Serum levels of CRP
serum levels of CRP will be measured using ELISA
Secondary Outcome Measures
Serum creatinine level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05927233
Brief Title
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
Official Title
Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cyanotic Heart Disease, Cardiopulmonary Bypass
Keywords
Paediatric population
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group M
Arm Type
Experimental
Arm Description
IV Methylprednisolone
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
IV Normal Saline
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
30 ml Normal saline
Primary Outcome Measure Information:
Title
Serum levels of Interleukin- 6
Description
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
Title
Serum levels of CRP
Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Saad Yousuf, MBBS, FCPS
Phone
+923003540362
Email
saad.yousuf@aku.edu
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Saad Yousuf, MBBS, FCPS
Phone
00923003540362
Email
saad.yousuf@aku.edu
First Name & Middle Initial & Last Name & Degree
mohammad Hamid, FCPS
First Name & Middle Initial & Last Name & Degree
Syed Shabir Ahmed, FCPS
First Name & Middle Initial & Last Name & Degree
Waris Ahmed, FRCS
First Name & Middle Initial & Last Name & Degree
Khalid Samad, FCPS
First Name & Middle Initial & Last Name & Degree
Khalid Siddiqui, FCPS
First Name & Middle Initial & Last Name & Degree
Muhammad Saad Yousuf, FCPS
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23602068
Citation
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.
Results Reference
background
PubMed Identifier
33045104
Citation
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.
Results Reference
background
Learn more about this trial
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
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