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Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

NCT03823781 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2019-01-30

No results posted yet for this study

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

Interventions

DRUG

Milrinone

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

DRUG

Normal saline

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

Sponsors & Collaborators

  • Shanghai Children's Medical Center

    lead OTHER

Principal Investigators

  • Huiwen Chen, MD, PhD · Department of clinical research, Shanghai children's medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2021-01-31
Completion
2021-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823781 on ClinicalTrials.gov