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Completed

NCT Number: NCT01966237

Milrinone Pharmacokinetics and Acute Kidney Injury

Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through urinary biomarkers can predict altered drug levels is unknown.

Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting in low blood pressure. Dose adjustments are not currently possible because of the late rise in SCr, and are based on clinical parameters that may lead to clinically relevant over or under-dosing. Thus, this study will address an important knowledge gap being the first to use elevations of AKI biomarker concentrations to anticipate increased milrinone levels.

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Key information

Conditions

Congenital Heart Disease Acute Kidney Injury Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing cardiothoracic surgery with cardiopulmonary bypass
  • weight greater than 2500 grams (5 pounds 8 ounces) at the time of surgery
  • gestational age > 36 weeks
  • age less < to 1 year
  • infants with complex congenital heart disease
  • use of milrinone in the intra-operative and post-operative period.

Exclusion criteria

  • Pre-existing kidney disease (structural and functional abnormalities) as determined by the Principal Investigator
  • use of aminoglycosides within 48 hours of planned surgery
  • cardiac arrest prior to cardiac surgery
  • extracorporeal membrane oxygenation prior to cardiac surgery
  • urinary tract infection prior to surgery
  • repair of an isolated atrial or ventricular septal defect

Treatment and study plan

Primary outcomes

  1. Biomarker elevation and milrinone clearance

    Time frame: By 24 hours

    The primary outcome variables for Aim 1 are an elevation in urinary AKI biomarkers to predict a 25% reduction in milrinone clearance.

Secondary outcomes

  1. Creatinine elevation and milrinone clearance

    Time frame: by 72 hours

    The secondary outcome variables for Aim 2 include a 50-75% increase in SCr to predict a 25% reduction in milrinone clearance

Other outcomes

  1. Hemodynamic parameters and AKI

    Time frame: by 72 hours

    Parameters of hemodynamic function defined by a decrease in central venous pressure of > 5cmH20, and/or a decrease in superior vena cava saturation by >10% at 12-36 hours after cardiopulmonary bypass. These surrogate markers of clinical outcome will be correlated with the following: operative mortality, longer time to achieve negative fluid balance, higher vasoactive inotrope score and longer intensive care and hospital length of stay.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY

Acronym: MIL-PK

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Oct 21, 2013
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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