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

NCT03527160 | Completed Results

• 1 other identifier: CIN001 - NINJA NGAL
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Kidney Injury; Nephrotoxicity

Keywords

AKI; NGAL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Point of Care NGAL Reliability Compared to Clinical Urinary NGAL

  7 Days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All inpatients in non-ICU settings at participating pediatric institutions

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• BioPorto Diagnostics: collaborator

Study Sites (2)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

This study had a relatively small sample size with only 27 participants developing AKI. Additionally, this study was performed in non-critically ill children and the findings may not be applicable to a broader population of hospitalized children and adults.

Results Point of Contact

• Title: Dr. Stuart Goldstein
• Organization: Cincinnati Children's Hospital Medical Center

stuart.goldstein@cchmc.org

513-636-2209

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 17, 2018
• Study Start: April 23, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2019
• Last Updated: October 5, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)