Methylprednisolone in neonatal cardiac surgery: reduced inflammation without improved clinical outcome.
Juho Keski-Nisula, Eero Pesonen, Klaus T Olkkola...
https://pubmed.ncbi.nlm.nih.gov/23602068Actively Recruiting
Phase 4
Age: 1Month - 18Years
All Genders
ID05927233
Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial
Led by Aga Khan University · Updated on 2024-07-31
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of steroids on the early postoperative inflammatory response in children undergoing elective congenital heart surgery using cardiopulmonary bypass (CPB). The study focuses on pediatric patients with cyanotic and acyanotic heart disease who require CPB during their first cardiac surgery. The trial is a phase 4 randomized controlled study designed to monitor inflammatory markers and clinical outcomes related to steroid use in this setting. Participants will receive either intravenous methylprednisolone at a dose of 30 mg/kg (up to 500 mg) or intravenous normal saline as a placebo. These treatments are administered during the surgery involving CPB. The study includes two groups: an experimental group receiving methylprednisolone and a placebo comparator group receiving saline. The trial uses triple masking to ensure unbiased evaluation. During the study, blood samples will be collected before the first dose, immediately after protamine infusion, and at 24 and 48 hours following CPB. These samples will measure serum levels of interleukin-6, C-reactive protein (CRP), and creatinine to assess inflammatory and kidney function responses. Participants will be monitored closely in the cardiac intensive care unit during the initial 24 hours and followed up as per protocol. The total duration of participation varies based on these assessments and clinical care needs.
CONDITIONS
Brief Title
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
Who Can Participate
Age: 1Month - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children 1 month to 18 years of age
- Undergoing cardiac surgery for the first time requiring cardiopulmonary bypass
- Surgeries for both cyanotic and acyanotic heart disease
You will not qualify if you...
- Premature babies (born before 28 weeks gestation)
- Neonates
- Prior cardiac surgery requiring cardiopulmonary bypass
- Surgeries requiring cardiopulmonary bypass longer than 6 hours
- Surgeries requiring a second run of cardiopulmonary bypass
- Patients needing additional steroids during the first 24 hours in the cardiac ICU
- Patients who expire within the initial 24 hours of cardiac ICU stay
- Known immunodeficiency or use of immunomodulatory therapy
- Presence of two or more signs of active infection before surgery such as high fever, abnormal heart or respiratory rate, high white blood cell count, or elevated C-reactive protein
- Preoperative mechanical ventilation or need for inotropic agents or mechanical circulatory support
- Patients already receiving steroids
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day (day of surgery)
Participants receive a single dose of either Methylprednisolone or Normal Saline intravenously during their cardiac surgery involving cardiopulmonary bypass.
1 day with surgery and intervention
Post-operative Follow-up
Duration - 48 hours after surgery
Participants are monitored for inflammatory markers and clinical parameters immediately after surgery and up to 48 hours after cardiopulmonary bypass.
Multiple assessments within 48 hours post-surgery
Trial Site Locations
Total: 1 location
1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Actively Recruiting
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Research Team
M
Muhammad Saad Yousuf, MBBS, FCPS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass.
Ben Gibbison, José Carlos Villalobos Lizardi, Karla Isis Avilés Martínez...
https://pubmed.ncbi.nlm.nih.gov/33045104