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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
520
The study intervention is an intravenous infusion of milrinone or placebo.
The study intervention is an intravenous infusion of milrinone or placebo.
Shanghai Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants died within 30 days postoperatively
Time frame: up to 30 days postoperatively
Number of participants developed low cardiac output syndrome within the first 36 hours after initiation of study drug
Low cardiac output syndrome was defined as the following: clinical signs or symptoms (eg, tachycardia, oliguria, poor perfusion, or cardiac arrest) with or without a widened arterial-mixed venous oxygen saturation difference or metabolic acidosis; mechanical support of the circulation (eg, extracorporeal life support, ventricular assist device), a cardiac index determined by Pulse indicator continuous cardiac output (PiCCO) of \<2.2 L/min/m2
Time frame: 36 hours after initiation of study drug
Number of participants developed low cardiac output syndrome in the interval between 36 hours after initiation of study drug and the final Follow up. Cardiac index will be determined by Doppler echocardiography
Time frame: up to 30 days postoperatively
Change in Vasoactive Inotrope Score.
Vasoactive Inotrope Score=100\*Epinephrine dose (ug/kg/min)+100\*Norepinephrine dose (ug/kg/min)+10\*Dopamine dose (ug/kg/min)+10\*Dobutamine dose (ug/kg/min) +10,000\*Vasopressin dose (units/kg/min) +10\*Milrinone dose (ug/kg/min)
Time frame: 36 hours after initiation of study drug
Length of intensive care stay.
Length of intensive care stay will be calculated from date of ICU admission to date of ICU discharge
Time frame: up to 30 days postoperatively or until ICU discharge.
Length of hospital stay.
Length of hospital stay will be calculated from date of hospital admission to date of hospital discharge
Time frame: up to 30 days postoperatively or until hospital discharge
Duration of mechanical ventilation.
Duration of mechanical ventilation will be calculated from date and time of ICU admission to date and time of extubation
Time frame: up to 30 days postoperatively or until extubation
Number of participants with improvement of ventriculoarterial coupling
ventriculoarterial coupling improvement will be assessed by means of ventriculoarterial coupling values shift closer to 1. ventriculoarterial coupling will be obtained as : (1-EF)/EF
Time frame: 36 hours after initiation of study drug
Number of participants requiring mechanical circulatory support.
eg. Extra-Corporeal Membrane Oxygenation, ventricular assist device
Time frame: up to 30 days postoperatively
Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline.
Cerebral and abdominal regional tissue oxygenation will be monitored
Time frame: 36 hours after initiation of study drug
Number of participants with treatment-related adverse events
Treatment-related adverse events will be evaluated by sponsor's drug safety surveillance reviewer
Time frame: 36 hours after initiation of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.