ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA) (NCT07751913) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)
800 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Timeframe: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
2
Specificity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Timeframe: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
3
Positive Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Timeframe: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
4
Negative Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Timeframe: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission