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

Acute Kidney Injury Clinical Trial

— NINJA NGAL  

Official title:

Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict Acute Kidney Injury in Children Research Multiple Nephrotoxic Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527160
• Other study ID #: CIN001 - NINJA NGAL
• Status: Completed
• Start date: April 23, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Nephrotoxicity

Locations

Country	Name	City	State
United States	Children's of Alabama	Birmingham	Alabama
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	BioPorto Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL	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	9 Days
Secondary	Point of Care NGAL Reliability Compared to Clinical Urinary NGAL	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	7 Days