STeroids to REduce Systemic Inflammation After Infant Heart Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Congenital Heart Disease in Children, Inflammatory Response

In brief

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 is a prospective, double blind, multi-center, placebo-controlled safety and efficacy study. Blood samples will be collected from a subset of enrolled study participants to evaluate multiple dose methylprednisolone PK/PD. Participants will be randomized in a 1:1 fashion to intravenous methylprednisolone versus placebo. Study drug/placebo will be administered 8 to 12 hours before the anticipated start time of surgery and in the operating room at the time of initiation of cardiopulmonary bypass. Patients will be followed for primary and secondary outcomes for the duration of their hospitalization. Serious study drug-related adverse events will be collected for 7 days after the last dose of study drug.

Key facts

Study ID

NCT03229538

Run by

Kevin Hill

People needed

1263

Starts

2017-10-18

Expected to finish

2022-03-31

Last updated by the study team

2026-01-05

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• < 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

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• University of Florida Health - Shands Hospital — Gainesville, Florida, United States
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Advocate Children's Hospital — Oak Lawn, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Children's Hospital and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Children's Hospital and Medical Center — Omaha, Nebraska, United States
• Morgan Stanley Children's Hospital of New York Presbyterian — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine, Texas Children's Hospital — Houston, Texas, United States
• Utah/Primary Children's Medical Center — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.