Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

NCT03823781 | Unknown Phase 3

• 1 other identifier: SCMCIRB-K2018105
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Cardiac Output Syndrome; Cardiac Surgical Procedures; Infant

Outcome Measures

Primary Outcomes (2)

• Number of participants died within 30 days postoperatively

  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

  36 hours after initiation of study drug

Secondary Outcomes (9)

• 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

• Change in Vasoactive Inotrope Score.

  36 hours after initiation of study drug

• Length of intensive care stay.

  up to 30 days postoperatively or until ICU discharge.

• Length of hospital stay.

  up to 30 days postoperatively or until hospital discharge

• Duration of mechanical ventilation.

  up to 30 days postoperatively or until extubation

Study Arms (2)

milrinone

EXPERIMENTAL

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.

Drug: Milrinone

normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Milrinone DRUG

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

Also known as: Milrinone Lactate

milrinone

Normal saline DRUG

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

Also known as: Normal Saline 0.9% Infusion Solution Bag

normal saline

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

Shanghai Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Milrinone; Saline Solution

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Huiwen Chen, MD, PhD

  Department of clinical research, Shanghai children's medical center

  STUDY DIRECTOR

Central Study Contacts

Jihong Huang, MD, PhD

CONTACT

+8618930830766; huangjihong@scmc.com.cn

Zhuoming Xu, MD, PhD

CONTACT

+8618930830783; xuzhuoming@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 30, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

CN (1)