Clinical trial NCT03823781: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Low Cardiac Output Syndrome
Cardiac Surgical Procedures
Infant
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 520
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* Consent was withdrawn by participants' parent or guardian.

Primary outcomes:
measure: Number of participants died within 30 days postoperatively
timeFrame: up to 30 days postoperatively
measure: Number of participants developed low cardiac output syndrome within the first 36 hours after initiation of study drug
timeFrame: 36 hours after initiation of study drug
Secondary outcomes:
measure: 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
timeFrame: up to 30 days postoperatively
measure: Change in Vasoactive Inotrope Score.
timeFrame: 36 hours after initiation of study drug
measure: Length of intensive care stay.
timeFrame: up to 30 days postoperatively or until ICU discharge.
measure: Length of hospital stay.
timeFrame: up to 30 days postoperatively or until hospital discharge
measure: Duration of mechanical ventilation.
timeFrame: up to 30 days postoperatively or until extubation
measure: Number of participants with improvement of ventriculoarterial coupling
timeFrame: 36 hours after initiation of study drug
measure: Number of participants requiring mechanical circulatory support.
timeFrame: up to 30 days postoperatively
measure: Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline.
timeFrame: 36 hours after initiation of study drug
measure: Number of participants with treatment-related adverse events
timeFrame: 36 hours after initiation of study drug
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Department of clinical research, Shanghai children's medical center
name: Huiwen Chen, MD, PhD
role: STUDY_DIRECTOR
References: