Status:
UNKNOWN
Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants
Lead Sponsor:
Shanghai Children's Medical Center
Conditions:
Low Cardiac Output Syndrome
Cardiac Surgical Procedures
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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- Consent was withdrawn by participants' parent or guardian.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT03823781
Start Date
February 1 2019
End Date
July 1 2021
Last Update
January 30 2019
Active Locations (1)
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1
Shanghai Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127