Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants (NCT03823781) | Clinical Trial Compass
UnknownPhase 3
Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants
China520 participantsStarted 2019-02
Plain-language 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.
Who can participate
Age range
12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* Consent was withdrawn by participants' parent or guardian.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants died within 30 days postoperatively
Timeframe: up to 30 days postoperatively
2
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