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New treatment option for Cyanotic Heart Disease
Official title Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
ClinicalTrials.gov ID: NCT05927233
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, being studied as a potential treatment for cyanotic heart disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- Preoperative mechanical ventilation, and preoperative need of inotropic agents or mechanical circulatory support.
- Patient already receiving steroids
The study team makes the final eligibility decision.
Where it's taking place
- Karachi, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Karachi, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.