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ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
Sponsor: BioPorto Diagnostics
Summary
The purpose of this study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours of ICU admission. The study will assess how accurately the test predicts acute kidney injury by evaluating its sensitivity, specificity, positive predictive value, and negative predictive value. Participants will provide blood and urine samples for testing.
Official title: Validation of the ProNephro AKITM (NGAL) in Adult ICU Patients in the ICU at Risk of Moderate to Severe Acute Kidney Injury (ALPACA)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
800
Start Date
2026-08
Completion Date
2028-05
Last Updated
2026-08-07
Healthy Volunteers
No
Conditions
Interventions
ProNephro AKI™ (NGAL)
ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.