Evaluating Precision of Therapy - Milrinone

NCT01841177 | Completed Phase 2

• 1 other identifier: 1000032365
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease; Pediatrics; Milrinone; Cardiopulmonary Bypass; Therapeutic Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• LCOS,

  Composite outcome

  within first 48 hours

Secondary Outcomes (4)

• Therapeutic Levels

  +8, +16 hours

• Duration

  Duration of ICU stay or maximum of 1 week

• Dosage Adjustment

  Duration of infusion or maximum of 1 week

• Plasma Milrinone Levels

  Duration of infusion or maximum of 1 week

Study Arms (2)

Therapeutic Drug Monitoring

EXPERIMENTAL

The intervention is \[1\] regular measurement of milrinone levels; \[2\]physician feedback of plasma levels in experimental arm by the ICU pharmacist ( this process currently occurs for other drugs such as vancomycin).

Drug: Milrinone

Standard Care

ACTIVE COMPARATOR

Standard care involves titration of milrinone infusion based on clinical examination by the treating team. The control group will receive standard care: with milrinone dose modification on clinical assessment. Control patients will have milrinone plasma levels drawn but not analysed until the end of the study.

Drug: Milrinone

Interventions

Milrinone DRUG

Milrinone is a potent selective phosphodiesterase (PDE) type III inhibitor which stimulates myocardial function (inotropy), causes peripheral vasodilatation (afterload reduction) and improves myocardial relaxation (lusitropy).

Also known as: Milrinone Lactate Inj

Standard Care; Therapeutic Drug Monitoring

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Premature infants (\<36 weeks post-conceptual age) or weight less than 2.0 kg.
• Failure to provide consent

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (2)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Katherine Taylor, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 26, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)