Milrinone Pharmacokinetics and Acute Kidney Injury (MIL-PK)
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|ClinicalTrials.gov 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
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|
|Study Type :||Observational|
|Estimated Enrollment :||74 participants|
|Observational Model:||Case Control|
|Official Title:||USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY|
|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
- 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.
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01966237
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Katja M Gist, DO, MSCS||University of Colorado, Denver|