Acute Kidney Injury
Conditions
Brief 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.
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
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
Males and females ≥ 22 years of age. Subjects must be admitted or admission pending 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 (unless otherwise specified): Vasoactive medication administration Mechanical ventilation Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula Serum Lactate greater than 2.5 mmol/L, within 6 hours prior to enrollment History (any) of solid organ transplantation, renal transplantation included only if more than 3 months prior History (any) of bone marrow transplantation Ability to provide written 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 or 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73m2. Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any of the following urologic procedure or urologic surgery within 30 days prior to ICU admission: Nephrostomy or nephroureteral stent placement Ureteral stent placement or exchange Ureteroscopy Lithotripsy Transurethral resection of the prostate Transurethral resection of bladder tumor Renal biopsy Subjects that have had surgical nephrectomy less than 3 months prior to admission. Subjects that have been previously enrolled in this study. Subjects enrolled in an interventional pharmaceutical or device clinical trial ICU admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off | T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission | Percentage of evaluable participants with independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration of 172 ng/mL or greater, as measured using the ProNephro AKI™ assay. |
| Specificity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off | T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission | Percentage of evaluable participants without independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration below 172 ng/mL, as measured using the ProNephro AKI™ assay. |
| Positive Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off | T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission | Percentage of evaluable participants with a T0 urinary NGAL concentration of 172 ng/mL or greater who have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay. |
| Negative Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off | T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission | Percentage of evaluable participants with a T0 urinary NGAL concentration below 172 ng/mL who do not have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay | Across protocol-defined collection time points through 72 hours after ICU admission | Pearson's r correlation coefficient for paired urinary and plasma NGAL concentrations measured in ng/mL at the same protocol-defined collection time points. |
| Agreement Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay | Across protocol-defined collection time points through 72 hours after ICU admission | Agreement between paired urinary and plasma NGAL concentrations measured in ng/mL at the same protocol-defined collection time points will be assessed using Passing-Bablok regression. |
| Change in Urinary NGAL Concentration Over Time by KDIGO Stage 2/3 Acute Kidney Injury Status | From T0 specimen collection through 72 hours after ICU admission | Change in urinary NGAL concentration, measured in ng/mL using the ProNephro AKI™ assay, will be evaluated over the protocol-defined collection time points and summarized separately for participants with and without independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury. |
| Percentage of Participants Developing KDIGO Stage 2/3 Acute Kidney Injury by Sequential Urinary NGAL Pattern | From T0 specimen collection through assessment of acute kidney injury status at 72 hours after ICU admission | Percentage of participants who develop independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury, summarized according to sequential urinary NGAL patterns at T0 and T1: negative to negative, negative to positive, positive to positive, and positive to negative. Positive or negative NGAL status will be determined using the 172 ng/mL cut-off. |
Outcome results
None listed