Evaluating Precision of Therapy - Milrinone
Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Heart Disease
Intervention: Milrinone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s): Katherine Taylor, MD, Principal Investigator, Affiliation: The Hospital for Sick Children
Overall contact: Katherine Taylor, MD, Phone: (416)813-7654, Ext: 202453, Email: katherine.taylor@sickkids.ca
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.
Clinical Details
Official title: Evaluating Precision of Therapy - Milrinone
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Dysrhythmia, LCOS, and Death
Secondary outcome: Therapeutic LevelsDuration Dosage Adjustment Plasma Milrinone Levels
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 heart disease at the Hospital for Sick Children, Toronto. We will randomize
patients to (1) receiving therapeutic drug monitoring or (2) control patients who receive
standard care. Standard care involves titration of milrinone infusion based on clinical
examination by the treating team. Control patients will have milrinone plasma levels drawn
but not analysed until the end of the study. The intervention is (1) regular measurement of
milrinone levels; and (2) physician feedback of plasma levels in experimental arm by the ICU
pharmacist. After obtaining consent, eligible subjects will be allocated to a trial group by
random assignment (sealed envelopes) within 3 strata in a 1: 1 allocation. These strata are <
2 years, 2- 10 years and > 10 years to ensure equal distribution of these age ranges in each
group for pharmacokinetic analysis. For the intervention group, sampling for milrinone
levels will occur at 0 hours (upon arrival to ICU with routine admission blood collection)
and approximately every 6- 8 hours (whenever the line is accessed for routine blood work).
The last sample will be taken 6-8 hours after cessation of infusion, or if the patient
leaves the ICU, or the maximum amount of blood sampling has been reached or after 7 days for
children weighing more than 8 kgs (or 5 days for children weighing less than 8 kgs), which
ever comes first. Follow-up will be exclusively during the period of hospitalization in the
ICU until ICU discharge. An optional algorithm with a proposed titration for milrinone will
be provided for use at the discretion of the treating team. Clinical outcomes will be
measured as a composite outcome of dysrhythmia, LCOS and death.
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- Premature infants (<36 weeks post-conceptual age) or weight less than 2. 0 kg.
- Failure to provide consent
Locations and Contacts
Katherine Taylor, MD, Phone: (416)813-7654, Ext: 202453, Email: katherine.taylor@sickkids.ca
Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting Katherine Taylor, Email: katherine.taylor@sickkids.ca
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting Katherine Taylor, MD, Phone: (416)813-7654, Ext: 202453, Email: katherine.taylor@sickkids.ca Christopher Parshuram, MD, Sub-Investigator Steven Schwartz, MD, Sub-Investigator
Additional Information
Starting date: April 2013
Last updated: December 19, 2014
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