Assessing a lab test for identifying risk of acute kidney injury in ICU patients
Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults (EPACRA-AKI)
This study is testing a new lab test to see if it can help doctors identify ICU patients at risk for serious kidney problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | BioPorto Diagnostics Industry-sponsored |
| Locations | 12 sites (Birmingham, Alabama and 11 other locations) |
| Trial ID | NCT06652100 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood and urine samples from adult patients admitted to intensive care units to evaluate the effectiveness of the ProNephro AKI (NGAL) assay. The study focuses on identifying patients at risk for moderate to severe acute kidney injury based on specific clinical criteria. Participants must meet certain inclusion criteria related to their ICU admission and health status, while those in special populations or receiving kidney replacement therapy are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who are admitted to an ICU and meet specific clinical criteria indicating a risk for acute kidney injury.
Not a fit: Patients who are pregnant, lactating, or receiving kidney replacement therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of acute kidney injury in critically ill patients.
How similar studies have performed: Other studies have shown promise in using biomarkers like NGAL for assessing kidney injury risk, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 11 other locations
- The University of Alabama — Birmingham, Alabama, United States (Recruiting)
- UC Davis — Sacramento, California, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Not_yet_recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- Columbia University — New York, New York, United States (Recruiting)
- Wake Forest University — Winston-Salem, North Carolina, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Ute Feger Director Clinical Affairs, PhD
- Email: ClinicalAffairs@bioporto.com
- Phone: 844-424-6767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.