Health TrialsbyHealthPanel

Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery

ConditionsCyanotic Heart DiseaseCardiopulmonary Bypass
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-18
SponsorAga Khan University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pre-mature babies (< 28 weeks at birth)

Neonates

Prior cardiac requiring CPB

Surgeries requiring CPB > 6 hours

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisolone

    Drug

    30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg

  • Saline

    Drug

    30 ml Normal saline

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group MExperimental treatment 1 intervention
Group B: Group PPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum levels of Interleukin- 6

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
2

Serum levels of CRP

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 outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aga Khan University

Lead sponsor

Source ClinicalTrials.gov
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