An observational study in Acute Kidney Injury and Nephrotoxicity, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 134 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
All inpatients in non-ICU settings at participating pediatric institutions
Exclusion Criteria:
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
Time frame: 9 Days
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
Time frame: 7 Days
| Milestone | NINJA |
|---|---|
| Started | 134 |
| Completed | 113 |
| Not completed | 21 |
| Withdrew: No urine collected | 13 |
| Withdrew: No clinical serum creatinine collected | 6 |
| Withdrew: Did not meet inclusion | 2 |
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
| Participants | Any AKI | No AKI |
|---|---|---|
| NGAL >= 150 ng/mL | 3 | 6 |
| NGAL < 150 ng/mL | 24 | 80 |
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
| Participants | NGAL >= 150 ng/mL | NGAL<150 ng/mL |
|---|---|---|
| AKI | 10 | 16 |
| No AKI | 41 | 46 |
Collected over Maximum of 9 days of exposure. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NINJA | 0/113 (0%) | 0/113 (0%) | 0/113 (0%) |
Participants separated into these two groups during the analysis, depending on whether they developed AKI per KDIGO serum creatinine guidelines during the course of their participation in the study.
| Age, Continuous(years) | Any AKI | No AKI | Total |
|---|---|---|---|
| Median | 16.2 (12.1 to 19.1) | 12.0 (5.9 to 18.0) | 13.2 (6.7 to 18.2) |
| Sex: Female, Male(Participants) | Any AKI | No AKI | Total |
|---|---|---|---|
| Female | 7 | 45 | 52 |
| Male | 20 | 41 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Any AKI | No AKI | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 27 | 83 | 110 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Any AKI | No AKI | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 12 | 15 |
| White | 24 | 66 | 90 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 5 | 5 |
| Weight(kilograms) | Any AKI | No AKI | Total |
|---|---|---|---|
| Median | 47.1 (32.5 to 66.3) | 39.9 (18.0 to 53.0) | 42.3 (21.0 to 56.2) |
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Plan to share: No
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Children's Hospital Medical Center, Cincinnati