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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03823781
Other study ID # SCMCIRB-K2018105
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 2019
Est. completion date July 2021

Study information

Verified date January 2019
Source Shanghai Children's Medical Center
Contact Jihong Huang, MD, PhD
Phone +8618930830766
Email huangjihong@scmc.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date July 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility 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- Consent was withdrawn by participants' parent or guardian.

Study Design


Intervention

Drug:
Milrinone
The study intervention is an intravenous infusion of milrinone or placebo.
Normal saline
The study intervention is an intravenous infusion of milrinone or placebo.

Locations

Country Name City State
China Shanghai Shanghai Children's Medical Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants died within 30 days postoperatively up to 30 days postoperatively
Primary 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 36 hours after initiation of study drug
Secondary 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 up to 30 days postoperatively
Secondary 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) 36 hours after initiation of study drug
Secondary Length of intensive care stay. Length of intensive care stay will be calculated from date of ICU admission to date of ICU discharge up to 30 days postoperatively or until ICU discharge.
Secondary Length of hospital stay. Length of hospital stay will be calculated from date of hospital admission to date of hospital discharge up to 30 days postoperatively or until hospital discharge
Secondary Duration of mechanical ventilation. Duration of mechanical ventilation will be calculated from date and time of ICU admission to date and time of extubation up to 30 days postoperatively or until extubation
Secondary 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 36 hours after initiation of study drug
Secondary Number of participants requiring mechanical circulatory support. eg. Extra-Corporeal Membrane Oxygenation, ventricular assist device up to 30 days postoperatively
Secondary Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline. Cerebral and abdominal regional tissue oxygenation will be monitored 36 hours after initiation of study drug
Secondary Number of participants with treatment-related adverse events Treatment-related adverse events will be evaluated by sponsor's drug safety surveillance reviewer 36 hours after initiation of study drug
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