Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Children's Medical Center
• Treatments: Milrinone

Criteria

Inclusion Criteria:

• Age younger than 12 months

• Without pre-operative low cardiac output syndrome

• Bi-ventricular repair of congenital heart disease involving cardiopulmonary bypass

• Informed consent obtained from each participant's parent or guardian

Exclusion Criteria:

• A body weight <2 kg

• Prematurity (birth <36 weeks postconceptual age)

• Renal dysfunction ( Creatinine>1.5mg/dL 48 hours before surgery)

• Low cardiac output syndrome or hypotension on arrival to ICU from OR

• Cardiopulmonary resuscitation before surgery

• Platelet count<80,000/mm3 before surgery

• Left ventricular outflow tract obstruction before surgery

• Ventricular arrhythmia before surgery

• Without femoral artery catheter before arriving in the ICU

• Consent was withdrawn by participants' parent or guardian.