Cardiopulmonary Bypass, Cyanotic Heart Disease
Conditions
Keywords
Paediatric population
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).
Interventions
DRUGMethylprednisolone
30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg
DRUGSaline
30 ml Normal saline
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of Interleukin- 6 | 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 Interleukin- 6 will be measured using ELISA |
| Serum levels of CRP | 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 will be measured using ELISA |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Pakistan
Contacts
Primary ContactMuhammad Saad Yousuf, MBBS, FCPS
Outcome results
None listed