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Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

Primary Purpose

Low Cardiac Output Syndrome, Cardiac Surgical Procedures, Infant

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Milrinone

Normal saline

About this trial

This is an interventional treatment trial for Low Cardiac Output Syndrome

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept 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Consent was withdrawn by participants' parent or guardian.

Sites / Locations

Shanghai Shanghai Children's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

milrinone

normal saline

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of participants died within 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

Secondary Outcome Measures

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

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)

Length of intensive care stay.

Length of intensive care stay will be calculated from date of ICU admission to date of ICU discharge

Length of hospital stay.

Length of hospital stay will be calculated from date of hospital admission to date of 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

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

Number of participants requiring mechanical circulatory support.

eg. Extra-Corporeal Membrane Oxygenation, ventricular assist device

Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline.

Cerebral and abdominal regional tissue oxygenation will be monitored

Number of participants with treatment-related adverse events

Treatment-related adverse events will be evaluated by sponsor's drug safety surveillance reviewer

Full Information

NCT ID

NCT03823781

First Posted

January 25, 2019

Last Updated

January 29, 2019

Sponsor

Shanghai Children's Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03823781

Brief Title

Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2019 (Anticipated)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Cardiac Output Syndrome, Cardiac Surgical Procedures, Infant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

milrinone

Arm Type

Experimental

Arm 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.

Arm Title

normal saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Milrinone

Other Intervention Name(s)

Milrinone Lactate

Intervention Description

The study intervention is an intravenous infusion of milrinone or placebo.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

Normal Saline 0.9% Infusion Solution Bag

Intervention Description

The study intervention is an intravenous infusion of milrinone or placebo.

Primary Outcome Measure Information:

Title

Number of participants died within 30 days postoperatively

Time Frame

up to 30 days postoperatively

Title

Number of participants developed low cardiac output syndrome within the first 36 hours after initiation of study drug

Description

Time Frame

36 hours after initiation of study drug

Secondary Outcome Measure Information:

Title

Time Frame

up to 30 days postoperatively

Title

Change in Vasoactive Inotrope Score.

Description

Time Frame

36 hours after initiation of study drug

Title

Length of intensive care stay.

Description

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.

Title

Length of hospital stay.

Description

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

Title

Duration of mechanical ventilation.

Description

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

Title

Number of participants with improvement of ventriculoarterial coupling

Description

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

Title

Number of participants requiring mechanical circulatory support.

Description

eg. Extra-Corporeal Membrane Oxygenation, ventricular assist device

Time Frame

up to 30 days postoperatively

Title

Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline.

Description

Cerebral and abdominal regional tissue oxygenation will be monitored

Time Frame

36 hours after initiation of study drug

Title

Number of participants with treatment-related adverse events

Description

Treatment-related adverse events will be evaluated by sponsor's drug safety surveillance reviewer

Time Frame

36 hours after initiation of study drug

10. Eligibility

Sex

All

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jihong Huang, MD, PhD

Phone

+8618930830766

huangjihong@scmc.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhuoming Xu, MD, PhD

Phone

+8618930830783

xuzhuoming@scmc.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huiwen Chen, MD, PhD

Organizational Affiliation

Department of clinical research, Shanghai children's medical center

Official's Role

Study Director

Facility Information:

Facility Name

Shanghai Shanghai Children's Medical Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jihong Huang, MD, PhD

Phone

+8618930830766

huangjihong@scmc.com.cn

First Name & Middle Initial & Last Name & Degree

Chunxiang Li, MD

Phone

+8618916611383

lichunxiang@scmc.com.cn

First Name & Middle Initial & Last Name & Degree

Huiwen Chen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

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