Clinical trial NCT05927233: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cyanotic Heart Disease
Cardiopulmonary Bypass
Keywords: Paediatric population
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Serum levels of Interleukin- 6
timeFrame: 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
measure: Serum levels of CRP
timeFrame: 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:
measure: Serum creatinine level
timeFrame: 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
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References:
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.
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.