drugset / Trial / NCT03823781

Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

NCT03823781

Phase 3 Unknown 520 enrolled Shanghai Children's Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. Participants will be randomized in a 1:1 ratio within 90 minutes after arriving in the intensive care unit (ICU), to receive either intravenous milrinone or placebo for 36 hours. Participants will be stratified according Vasoactive Inotrope Score after arriving in the ICU.

Timeline

Start
2019-02
Primary completion
2021-01
Completion
2021-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Milrinone Small molecule 0.75 ug/kg Intravenous

Indications

No indication recorded.