Acute Kidney Injury Clinical Trial
Official title:
Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) Ito Predict Acute Kidney Injury (AKI) in the NICU in Infants Receiving Multiple Nephrotoxic Medications (NICU NINJA NGAL)
Verified date | January 2024 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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 UAB/Children's of Alabama Hospital, 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 hypothesis of this NINJA NGAL study is that urine NGAL is highly sensitive to detect NTMx-associated AKI. UAB/Children's of Alabama is bringing urine NGAL measurement to the infants in the NICU to detect NTMX-associated AKI.
Status | Completed |
Enrollment | 148 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Year |
Eligibility | Inclusion Criteria: - all NICU inpatients under 1 year of age; greater than 4 days of age that are - Receiving 3 or more nephrotoxic medications on the same day OR - Receiving 3 or more days of an intravenous aminoglycoside or vancomycin Exclusion Criteria: - Less than 4 days of age - Currently being treated for a urinary tract infection - Presence of an acute kidney injury prior to enrollment |
Country | Name | City | State |
---|---|---|---|
United States | Children's of Alabama | Birmingham | Alabama |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | Children's Hospital Medical Center, Cincinnati |
United States,
Stoops C, Gavigan H, Krallman K, Anderson N, Griffin R, Slagle C, House S, Goldstein SL, Askenazi DJ. The Utility of Urinary NGAL as an Alternative for Serum Creatinine to Detect Acute Kidney Injury in Infants Exposed to Nephrotoxic Medications in the Neo — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with elevated urine NGAL | NGAL is an early, sensitive, non-invasive urine biomarker for AKI. | Daily for one week after meeting criteria for nephrotoxic medication exposure |
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