Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
92 participants
OBSERVATIONAL
2013-09-30
2018-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Acute kidney injury
AKI defined by an elevation in urinary AKI biomarkers
No interventions assigned to this group
No acute kidney injury
No AKI defined by normal urinary AKI biomarkers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Day
1 Year
ALL
No
Sponsors
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Thrasher Research Fund
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Katja M Gist, DO, MSCS
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Mizuno T, Gist KM, Gao Z, Wempe MF, Alten J, Cooper DS, Goldstein SL, Vinks AA. Developmental Pharmacokinetics and Age-Appropriate Dosing Design of Milrinone in Neonates and Infants with Acute Kidney Injury Following Cardiac Surgery. Clin Pharmacokinet. 2019 Jun;58(6):793-803. doi: 10.1007/s40262-018-0729-3.
Gist KM, Cooper DS, Wrona J, Faubel S, Altmann C, Gao Z, Marino BS, Alten J, Hock KM, Mizuno T, Vinks AA, Joy MS, Wempe MF, Bennett MR, Goldstein SL. Acute Kidney Injury Biomarkers Predict an Increase in Serum Milrinone Concentration Earlier Than Serum Creatinine-Defined Acute Kidney Injury in Infants After Cardiac Surgery. Ther Drug Monit. 2018 Apr;40(2):186-194. doi: 10.1097/FTD.0000000000000496.
Gist KM, Goldstein SL, Wrona J, Alten JA, Basu RK, Cooper DS, Soranno DE, Duplantis J, Altmann C, Gao Z, Faubel S. Kinetics of the cell cycle arrest biomarkers (TIMP-2*IGFBP-7) for prediction of acute kidney injury in infants after cardiac surgery. Pediatr Nephrol. 2017 Sep;32(9):1611-1619. doi: 10.1007/s00467-017-3655-y. Epub 2017 Apr 5.
Other Identifiers
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2013-2507
Identifier Type: -
Identifier Source: org_study_id
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