CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 92 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01966237
NCT01966237N/ACompleted

USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY

Children's Hospital Medical Center, Cincinnati·observational·Posted Oct 21, 2013·Updated Jun 22, 2021

In Brief

An observational study for Congenital Heart Disease and Acute Kidney Injury. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 21, 2013
Enrollment StartSep 1, 2013
Primary CompletionJul 31, 2017
Study CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.7 years ago