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

NCT05927233 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-31

No results posted yet for this study

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).

Conditions

  • Cyanotic Heart Disease
  • Cardiopulmonary Bypass

Interventions

DRUG

Methylprednisolone

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

DRUG

Saline

30 ml Normal saline

Sponsors & Collaborators

  • Aga Khan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-04-30
Completion
2025-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05927233 on ClinicalTrials.gov