Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: Low Cardiac Output Syndrome; Infant; Cardiac Surgical Procedures

Treatments: Drug: Normal saline; Drug: Milrinone

Study type: Interventional

Funder types: Other

Identifiers

NCT03823781

SCMCIRB-K2018105

Details and patient eligibility

About

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.

Enrollment: 520 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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• Consent was withdrawn by participants' parent or guardian.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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520 participants in 2 patient groups, including a placebo group

milrinone

Experimental group

Description:

milrinone milrinone will be administered intravenously at a rate of 0.75ug/kg/min for 35 hours, and baseline catecholamines will be administered at the discretion of the physician.

Treatment:

Drug: Milrinone

normal saline

Placebo Comparator group

Description:

placebo placebo (normal saline) will be administered intravenously for 35 hours, and baseline catecholamines will be administered at the discretion of the physician.

Treatment:

Drug: Normal saline