STeroids to REduce Systemic Inflammation After Infant Heart Surgery
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
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 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.