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Набор скоро начнётся NCT07751913

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

— Наблюдательное Acute Kidney Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ProNephro AKI™ (NGAL).
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury. Базовые параметры: от 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission]
Вторичные конечные точки (4)
  • Correlation Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From T0 specimen collection through assessment of acute kidney injury status at 72 hours after ICU admission]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07751913 · TD-0790

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗