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| Name | Class |
|---|---|
| ProPharma Group | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProNephro AKI (NGAL) | Diagnostic Test | ProNephro AKIâ„¢ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine. |
| Measure | Description | Time Frame |
|---|---|---|
| Cut off Establishment | 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. | 24hrs after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| Sub-Group analysis | 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. | 24hrs after ICU admission |
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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:
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
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Patients admitted to the ICU 22 years of age and older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| UC Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40802457 | Derived | Strader M, Imran S, Tariq A, Fraser C, Saghie E, Louis BC, Meade T, Stoyanov V, Cote JM, Twomey PJ, Murray PT. Clinical Implementation of Urinary Neutrophil Gelatinase-Associated Lipocalin Testing for Diagnosing Acute Kidney Injury in an Academic Tertiary Care Medical Centre. Kidney360. 2025 Dec 1;6(12):2119-2129. doi: 10.34067/KID.0000000887. Epub 2025 Aug 13. |
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urine and plasma
| Sacramento |
| California |
| 95817 |
| United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27109 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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