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A urine test that could foresee kidney danger in the ICU
NCT ID NCT07751913
First seen Aug 07, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This trial is testing whether a urine test called ProNephro AKI™ (NGAL) can accurately predict which critically ill adults in the intensive care unit (ICU) will develop moderate to severe acute kidney injury within 48 to 72 hours of admission. The study will enroll 800 adults who are in the ICU or about to be admitted, and will measure NGAL levels in their urine and blood. The goal is to see how well the test performs in terms of sensitivity, specificity, and predictive value, which could help doctors intervene earlier and improve patient care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ProNephro AKI™ (NGAL) urine test
- What this could lead to
- If accurate, this test could help doctors identify ICU patients at high risk of acute kidney injury earlier, potentially enabling timely interventions and better outcomes.
- What could go wrong
- The test may not be accurate enough in real-world ICU settings, and results from this validation study may not generalize to all patient populations. There are no direct risks from the test itself, but false results could affect clinical decisions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients admitted to the ICU 22 years of age and older
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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