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Not yet recruiting NCT07751913

ProNephro NGAL Test for Early Detection of Acute Kidney Injury in Adult ICU Patients (ALPACA)

— Observational Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ProNephro AKI™ (NGAL).
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Validation of the ProNephro AKITM (NGAL) in Adult ICU Patients in the ICU at Risk of Moderate to Severe Acute Kidney Injury (ALPACA)

Overview

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 test ProNephro AKI™ (NGAL)
    ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.

Primary outcome measures

  • Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off [Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission]
  • Specificity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off [Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission]
  • Positive Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off [Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission]
  • Negative Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off [Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission]
Secondary outcome measures (4)
  • Correlation Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay [Time frame: Across protocol-defined collection time points through 72 hours after ICU admission]
  • Agreement Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay [Time frame: Across protocol-defined collection time points through 72 hours after ICU admission]
  • Change in Urinary NGAL Concentration Over Time by KDIGO Stage 2/3 Acute Kidney Injury Status [Time frame: From T0 specimen collection through 72 hours after ICU admission]
  • Percentage of Participants Developing KDIGO Stage 2/3 Acute Kidney Injury by Sequential Urinary NGAL Pattern [Time frame: From T0 specimen collection through assessment of acute kidney injury status at 72 hours after ICU admission]

Eligibility criteria

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

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; or 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07751913 · TD-0790

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗