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Milrinone Pharmacokinetics and Acute Kidney Injury (MIL-PK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01966237
Recruitment Status : Unknown
Verified February 2015 by Katja Gist, University of Colorado, Denver.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : February 4, 2015
Thrasher Research Fund
Information provided by (Responsible Party):
Katja Gist, University of Colorado, Denver

Brief Summary:

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.

Condition or disease
Congenital Heart Disease Acute Kidney Injury

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Study Type : Observational
Estimated Enrollment : 74 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : September 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Acute kidney injury
AKI defined by an elevation in urinary AKI biomarkers
No acute kidney injury
No AKI defined by normal urinary AKI biomarkers

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients less than or equal to 1 year who present for cardiac surgery at Cincinnati Children's Hospital Medical Center who meet the eligibility criteria.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01966237

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Thrasher Research Fund
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Principal Investigator: Katja M Gist, DO, MSCS University of Colorado, Denver
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Katja Gist, Assistant Professor of Pediatrics, University of Colorado, Denver Identifier: NCT01966237    
Other Study ID Numbers: 2013-2507
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Acute Kidney Injury
Heart Diseases
Wounds and Injuries
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases