Status:
COMPLETED
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
Lead Sponsor:
Kevin Hill
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Congenital Heart Disease in Children
Inflammatory Response
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE3
Brief Summary
This study's objective is to determine the pharmacokinetics (PK)/pharmacodynamics (PD), safety and efficacy of methylprednisolone in infants undergoing heart surgery with cardiopulmonary bypass. This ...
Detailed Description
Overview: Congenital heart diseases (CHD) are the most common birth defects, occurring in nearly 1% of live births. Every year, an estimated 40,000 infants born in the U.S. suffer from CHD. Despite a...
Eligibility Criteria
Inclusion
- Age \< 1 year at the time of surgery
- Undergoing heart surgery with CPB as part of standard clinical care
- Availability and willingness of the parent/legally authorized representative to provide written informed consent
Exclusion
- \< 37 weeks adjusted gestational age at time of surgery
- Any oral or intravenous steroid treatment within two days of surgery
- Any patient receiving any of the following medications within 2 days of surgery:
- Amphotericin B, aminoglutethimide, anticholinesterases, warfarin, P450 3A4 inducers including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, bosentan and nafcillin or P450 3A4 inhibitors including (but not limited to) clarithromycin, voriconazole, itraconazole, ketoconazole, ciprofloxacin, diltiazem, fluconazole, erythromycin and verapamil.
- Infection contraindicating steroid use
- Preoperative mechanical circulatory support or active resuscitation at the time of randomization
- Emergent surgery precluding steroid administration 8-12 hours before surgery
Key Trial Info
Start Date :
October 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
1263 Patients enrolled
Trial Details
Trial ID
NCT03229538
Start Date
October 18 2017
End Date
March 31 2022
Last Update
January 5 2026
Active Locations (23)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of Colorado, Denver
Aurora, Colorado, United States, 80045
3
University of Florida Health - Shands Hospital
Gainesville, Florida, United States, 32608
4
Ann & Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611-2605