Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults
- Conditions
- Acute Kidney Injury
- Registration Number
- NCT06652100
- Lead Sponsor
- BioPorto Diagnostics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Sub-Group analysis 24hrs after ICU admission Secondary objective is to explore independent cut-offs and estimate performance for NGAL in urine for the following patient subgroups:
Patients after cardiac surgery Patients with decompensating cirrhosis Patients with sepsis Male vs female subjects Sensitivity, specificity, negative and positive predictive values are to be calculated as applicable.
Trial Locations
- Locations (12)
The University of Alabama
🇺🇸Birmingham, Alabama, United States
UC Davis
🇺🇸Sacramento, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Columbia University
🇺🇸New York, New York, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States