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

NCT ID: NCT03527160

Last Updated: 2021-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-23

Study Completion Date

2019-06-30

Brief Summary

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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

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Conditions

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Acute Kidney Injury Nephrotoxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioPorto Diagnostics

INDUSTRY

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's of Alabama

Birmingham, Alabama, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CIN001 - NINJA NGAL

Identifier Type: -

Identifier Source: org_study_id

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