Acute Kidney Injury
Conditions
Keywords
NGAL, ICU, adult
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.
Interventions
DIAGNOSTIC_TESTProNephro AKI (NGAL)
ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
Sponsors
ProPharma Group
BioPorto Diagnostics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed