N/A
Completed N=134
Assessment of Urinary NGAL to Predict AKI in Children Receiving Multiple Nephrotoxic Medications
Source: ClinicalTrials.gov NCT03527160 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL — 3; 6; 24; 80 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL |
3; 6; 24; 80 | — |
| SECONDARY Point of Care NGAL Reliability Compared to Clinical Urinary NGAL |
10; 16; 41; 46 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03527160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.