Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications

Completed

• Conditions: Nephrotoxicity; Acute Kidney Injury

• Registration Number: NCT03527160
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Nephrotoxic medication (NTMx) exposure is one of the most commonly cited causes of acute kidney injury (AKI) in hospitalized children, and is the primary cause of AKI in 16% of cases. Through initial work at Cincinnati Children's Medical Center, NTMx exposure was found to be potentially modifiable and the associated AKI is an avoidable adverse safety event. Currently, only serum Creatinine monitoring is available to monitor for NTMx-associated AKI. The hypotheses of this NINJA NGAL study are that (1) urine NGAL is highly sensitive to detect NTMx-associated AKI, and (2) Bedside test of urine from high risk NTMx-exposed patients are adequate and reliable compared to urine NGAL measured from the clinical platform.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-23
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Primary Completion: 2019-05-31
• Study Completion: 2019-06-30
• Results First Submitted: 2021-05-26
• Results First Submitted QC: 2021-05-26
• Results First Posted: 2021-06-18
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Receiving 3 or more nephrotoxic medications on the same day OR
• Receiving 3 or more days of an intravenous aminoglycoside or vancomycin

Exclusion Criteria

• Currently being treated for a urinary tract infection
• Presence of an acute kidney injury prior to enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL	9 Days	AKI, defined as a 50% rise in serum Creatinine over baseline or a 0.3 mg/dL rise within 48 hours, will be first detected by a rise in Urinary NGAL

Secondary Outcome Measures

Name	Time	Method
Point of Care NGAL Reliability Compared to Clinical Urinary NGAL	7 Days	A POC urinary NGAL will be determined from a colorimetric assay that determines risk of AKI, which will later be compared to NGAL values from the clinical assay

Trial Locations

Locations (2)

Children's of Alabama; 🇺🇸 Birmingham, Alabama, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States