Status:
COMPLETED
Evaluating Precision of Therapy - Milrinone
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
Children with congenital heart disease have significant morbidity including low cardiac output syndrome and subsequent organ dysfunction that may be prevented by optimization of circulatory function. ...
Detailed Description
The proposed trial is a pilot of an open label, randomized trial of milrinone therapeutic drug monitoring in patients \< 18 years treated with milrinone following open-heart surgery for congenital hea...
Eligibility Criteria
Inclusion
- Admitted to a Pediatric (0 - 18 years) Intensive Care Unit following cardiopulmonary bypass (CPB) and surgery for congenital heart disease.
- Clinical decision by treating team to start milrinone infusion.
- Anticipated to receive milrinone infusion for more than 24hs. This limit will increase the proportion of sicker children in the sample, increasing the power of the study.
- Has an arterial line, and a central venous line defined as radiologically confirmed line
- Informed consent obtained
Exclusion
- Premature infants (\<36 weeks post-conceptual age) or weight less than 2.0 kg.
- Failure to provide consent
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01841177
Start Date
April 1 2013
End Date
August 1 2020
Last Update
January 6 2022
Active Locations (2)
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1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8