Acute Kidney Injury, Nephrotoxicity
Conditions
Keywords
AKI, NGAL
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.
Interventions
None listed
Sponsors
BioPorto Diagnostics
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Any AKI Patients developed AKI during study | 27 |
| No AKI Patients did not develop AKI over the course of the study | 86 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inclusion | 2 |
| Overall Study | No clinical serum creatinine collected | 6 |
| Overall Study | No urine collected | 13 |
Baseline characteristics
| Characteristic | Any AKI | Total | No AKI |
|---|---|---|---|
| Age, Continuous | 16.2 years | 13.2 years | 12.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 110 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 15 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) White | 24 Participants | 90 Participants | 66 Participants |
| Sex: Female, Male Female | 7 Participants | 52 Participants | 45 Participants |
| Sex: Female, Male Male | 20 Participants | 61 Participants | 41 Participants |
| Weight | 47.1 kilograms | 42.3 kilograms | 39.9 kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 113 |
| other Total, other adverse events | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Any AKI | Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL | NGAL >= 150 ng/mL | 3 Participants |
| Any AKI | Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL | NGAL < 150 ng/mL | 24 Participants |
| No AKI | Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL | NGAL >= 150 ng/mL | 6 Participants |
| No AKI | Number of Patients With Nephrotoxic Medication Associated AKI Detected by Urinary NGAL | NGAL < 150 ng/mL | 80 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Any AKI | Point of Care NGAL Reliability Compared to Clinical Urinary NGAL | AKI | 10 Participants |
| Any AKI | Point of Care NGAL Reliability Compared to Clinical Urinary NGAL | No AKI | 41 Participants |
| No AKI | Point of Care NGAL Reliability Compared to Clinical Urinary NGAL | AKI | 16 Participants |
| No AKI | Point of Care NGAL Reliability Compared to Clinical Urinary NGAL | No AKI | 46 Participants |