drugset / Trial / NCT01841177

Evaluating Precision of Therapy - Milrinone

NCT01841177

Phase 2 Completed 52 enrolled The Hospital for Sick Children
RandomizedParallel-groupOpen-labelTreatment

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. More than half of these children receive milrinone. Clinical evaluation cannot distinguish between patients with sub-therapeutic, therapeutic, and toxic milrinone drug levels. Consequently children who require pharmacologic circulatory support may be receiving sub-optimal dosing, and children who do not need milrinone may be receiving milrinone unnecessarily. The primary objective of this study is to determine if optimizing milrinone levels with therapeutic drug monitoring in critically ill children following cardiac surgery improves clinical outcomes and reduces the duration of milrinone infusion. This study hypothesizes that optimizing milrinone levels with therapeutic drug monitoring in critically ill children following cardiac surgery will improve clinical outcomes and reduce the duration of milrinone infusion.

Timeline

Start
2013-04
Primary completion
2020-08
Completion
2020-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Milrinone Small molecule