NCT03823781.

Study name	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
Methods	Randomised, multi‐centre, double‐blind, placebo‐controlled study
Participants	520 infants up to 12 months of age
Interventions	Intervention: milrinone will be administered intravenously at a rate of 0.75 μg/kg/min for 35 hours Control: 0.9% normal saline will be administered intravenously for 35 hours Co‐interventions: in both groups, baseline catecholamines will be administered at the discretion of the physician
Outcomes	Primary outcome(s) 30‐day mortality LCOS within 36 hours of surgery Secondary outcome(s) LCOS after 36 hours post‐surgery Change in vasoactive inotrope score Length of intensive care stay Length of hospital stay Duration of mechanical ventilation Number of participants with improvement of ventriculoarterial coupling Number of participants requiring mechanical circulatory support Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline Number of participants with treatment‐related adverse events
Starting date	February 2019
Contact information	Contact 1: Jihong Huang, MD, PhD Telephone: + 8618930830766 Email: huangjihong@scmc.com.cn Contact 2: Zhuoming Xu, MD, PhD Telephone: + 8618930830783 Email: xuzhuoming@scmc.com.cn
Notes	Funding source: unknown (other than "Shanghai Children's Medical Center (Responsible Party)") Declarations of interest: not available

AF: atrial fibrillation; CHICU: congenital heart intensive care unit; JET: junctional ectopic tachycardia; LCOS: low cardiac output syndrome; SVT: supraventricular tachycardia; VF: ventricular fibrillation; VT: ventricular tachycardia