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Active, not recruiting Observational

Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults

NCT06652100 · tracked via the Priya Life Science Mexico tracker
Sponsor
BioPorto Diagnostics
Phase
Observational
Started
2024-10-28
Last updated
2025-11-19

Condition(s) studied

Acute Kidney Injury

Investigational drug(s) / intervention(s)

ProNephro AKI (NGAL)

ProNephro AKI (NGAL): ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.

Study summary

The purpose of this research is to collect blood and urine from adult patients admitted to an intensive care unit. This is to assess the performance of the ProNephro AKI (NGAL) assay (lab test) as an aid to identify patients at risk for acute kidney injury.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Male and females ≥ 22 years of age. Subjects must be admitted to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission. Subjects must have at least one of the following leading to admission to the ICU, or occurring within 24 hours of admission to the ICU: * Vasoactive medication administration * Mechanical ventilation * Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula * Mean arterial pressure (MAP) less than 60 (within 12 hrs. of ICU admission only) * Serum Lactate greater than 2.5 mmol/L * History of solid organ transplantation, renal transplantation included only if more than 3 months prior * History of bone marrow transplantation Subject with signed informed consent. Exclusion Criteria: Special populations including pregnant and lactating women, prisoners, or institutionalized individuals. Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission. Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling. Subjects with a known history of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 and under the care of a nephrologist. Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any urologic procedure or urologic surgery immediately prior to admission to the ICU. Subjects that have had surgical nephrectomy less than 3 months prior to admission. Subjects that have been previously enrolled in this study. Subjects that do not have a baseline sCR within 6 months prior to ICU admission available. Subjects that did not sign the informed consent. Subjects enrolled in an interventional pharmaceutical or device clinical trial at time of ICU admission

Primary outcome measure(s)

  • Cut off Establishment — 24hrs after ICU admission
    The primary objective is to establish the cut-off value for the ProNephro AKI (NGAL) in critically ill adult patients (age 22 and older) admitted to ICU when used as an aid in risk assessment of the development of moderate to severe acute kidney injury (KDIGO stage 2/3) within 48-72 hrs. after admission.

Trial sites (12)

FacilityCityRegionStatus
The University of Alabama Birmingham Alabama
UC Davis Sacramento California
Yale University New Haven Connecticut
University of Chicago Chicago Illinois
Johns Hopkins University Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
University of Michigan Ann Arbor Michigan
University of New Mexico Albuquerque New Mexico
Columbia University New York New York
Wake Forest University Winston-Salem North Carolina
Cleveland Clinic Cleveland Ohio
Medical University of South Carolina Charleston South Carolina
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06652100 on ClinicalTrials.gov ↗ ← All trials in Mexico