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

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT03527160
• Collaborator: BioPorto Diagnostics (Industry)
• Enrollment: 134
• Locations: 2
• Actual Duration (Months): 14.2
• Patients Per Site: 67
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Nephrotoxicity

Study Design

• Study Type: Observational
• Actual Enrollment: 134 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict Acute Kidney Injury in Children Research Multiple Nephrotoxic Medications
• Actual Study Start Date: Apr 23, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: Jun 30, 2019

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's of Alabama	Birmingham	Alabama	United States	35233
2	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati
• BioPorto Diagnostics

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 13, 2018

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT03527160
• Other Study ID Numbers: CIN001 - NINJA NGAL
• First Posted: May 17, 2018
• Last Update Posted: Oct 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Children's Hospital Medical Center, Cincinnati: AKI; NGAL
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

Participant Flow

Arm/Group Title	NINJA
Arm/Group Description	Inpatients exposed to nephrotoxic medications
Period Title: Overall Study
STARTED	134
COMPLETED	113
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Any AKI	No AKI	Total
Arm/Group Description	Patients developed AKI during study	Patients did not develop AKI over the course of the study	Total of all reporting groups
Overall Participants	27	86	113
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	16.2	12.0	13.2
Sex: Female, Male (Count of Participants)
Female	7 25.9%	45 52.3%	52 46%
Male	20 74.1%	41 47.7%	61 54%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	3 3.5%	3 2.7%
Not Hispanic or Latino	27 100%	83 96.5%	110 97.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 2.3%	2 1.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 11.1%	12 14%	15 13.3%
White	24 88.9%	66 76.7%	90 79.6%
More than one race	0 0%	1 1.2%	1 0.9%
Unknown or Not Reported	0 0%	5 5.8%	5 4.4%
Weight (kilograms) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kilograms]	47.1	39.9	42.3

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL
Description	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
Time Frame	9 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Any AKI	No AKI
Arm/Group Description	Patients developed Nephrotoxic Medication Associated AKI during study	Patients did not develop Nephrotoxic Medication Associated AKI over the course of the study
Measure Participants	27	86
NGAL >= 150 ng/mL	3 11.1%	6 7%
NGAL < 150 ng/mL	24 88.9%	80 93%

2. Secondary Outcome

Title	Point of Care NGAL Reliability Compared to Clinical Urinary NGAL
Description	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
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NGAL >= 150 ng/mL	NGAL<150 ng/mL
Arm/Group Description	Participants who had an elevated point of care urine NGAL	Point of care urine NGAL less than 150 ng/mL
Measure Participants	51	62
AKI	10 37%	16 18.6%
No AKI	41 151.9%	46 53.5%

Adverse Events

Time Frame	Maximum of 9 days of exposure
Adverse Event Reporting Description	Adverse events were defined as any sign, symptoms, illness, clinically significant abnormal laboratory value or other adverse medical event the appeared for the first time or worsened during participation in the study AND were associated with the intervention in the study - urine collection. Serious adverse events were study defined adverse events that were considered life-threatening. Only events considered associated with the intervention in the study - urine collection- were collected.
Arm/Group Title	NINJA
Arm/Group Description	Inpatients exposed to nephrotoxic medications
All Cause Mortality
	NINJA
	Affected / at Risk (%)	# Events
Total	0/113 (0%)
Serious Adverse Events
	NINJA
	Affected / at Risk (%)	# Events
Total	0/113 (0%)
Other (Not Including Serious) Adverse Events
	NINJA
	Affected / at Risk (%)	# Events
Total	0/113 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.