Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| BioPorto Diagnostics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
All inpatients in non-ICU settings at participating pediatric institutions
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Cincinnati Children's Hospital Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NINJA | Inpatients exposed to nephrotoxic medications |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Any AKI | Patients developed AKI during study |
| BG001 | No AKI | Patients did not develop AKI over the course of the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 9 Days |
|
Maximum of 9 days of exposure
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NINJA | Inpatients exposed to nephrotoxic medications | 0 |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stuart Goldstein | Cincinnati Children's Hospital Medical Center | 513-636-2209 | stuart.goldstein@cchmc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2018 | May 26, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Urine
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Median | Inter-Quartile Range | kilograms |
|
| Units | Counts |
|---|
| 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 | Posted | Count of Participants | Participants | 7 Days |
|
|
|
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |