Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354467
• Other study ID #: 300000362
• Status: Completed
• Start date: January 28, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Description:

Nephrotoxic medication-induced acute kidney injury (NTM-AKI) is a relevant yet underdiagnosed morbidity in the neonatal intensive care unit (NICU). Up to 87% of very low birth weight infants are exposed to at least one nephrotoxic medication (NTM). NTM-AKI is associated with poor short and long-term outcomes. Presently, no treatments exist for AKI beyond supportive care.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Neonatal
• Nephrotoxicity

Intervention

Diagnostic Test:
• urine neutrophil gelatinase -associated lipocalin
urine biomarker is measured and batched procesessed

Locations

Country	Name	City	State
United States	Children's of Alabama	Birmingham	Alabama
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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