Milrinone Pharmacokinetics and Acute Kidney Injury
This trial is active, not recruiting.
|Conditions||congenital heart disease, acute kidney injury|
|Sponsor||Children's Hospital Medical Center, Cincinnati|
|Collaborator||Thrasher Research Fund|
|Start date||September 2013|
|End date||April 2015|
|Trial size||74 participants|
|Trial identifier||NCT01966237, 2013-2507|
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.
|Observational model||case control|
AKI defined by an elevation in urinary AKI biomarkers
No AKI defined by normal urinary AKI biomarkers
Biomarker elevation and milrinone clearance
time frame: By 24 hours
Creatinine elevation and milrinone clearance
time frame: by 72 hours
Male or female participants up to 1 year old.
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
|Official title||USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY|
|Principal investigator||Katja M Gist, DO, MSCS|
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