Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants

Last updated: January 29, 2019
Sponsor: Shanghai Children's Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03823781
SCMCIRB-K2018105
  • Ages < 12
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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  • Consent was withdrawn by participants' parent or guardian.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

Total Participants: 520
Study Start date:
February 01, 2019
Estimated Completion Date:
July 31, 2021

Connect with a study center

  • Shanghai Shanghai Children's Medical Center

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.