Milrinone Pharmacokinetics and Acute Kidney Injury
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Cardiology, Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | Any - 1 |
| Updated: | 2/7/2015 |
| Start Date: | September 2013 |
| End Date: | September 2014 |
| Contact: | Katja Gist, DO, MSCS |
| Email: | katja.gist@cchmc.org |
| Phone: | 513-636-1000 |
USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY
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.
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.
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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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