NCT03823781

Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

Prophylactic Milrinone Infusion for the Prevention Low Cardiac Output Syndrome After Corrective Surgery for Congenital Heart Disease in Infants: A Randomized, Multi-center, Double-blinded, Placebo-controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Low Cardiac Output Syndrome
• Cardiac Surgical Procedures
• Infant

Interventions

Type	Name	Description
DRUG	Milrinone	The study intervention is an intravenous infusion of milrinone or placebo.
DRUG	Normal saline	The study intervention is an intravenous infusion of milrinone or placebo.

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-01-01
• Completion: 2021-07-01
• First posted: 2019-01-30
• Last updated: 2019-01-30

Locations

1 site across 1 country: China