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Набор по приглашению NCT07653321

Acute Kidney Injury in Critically Ill Patients

— 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: Not applicable- observational study.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury. Базовые параметры: от 18 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
Китай
Следующий шаг
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Официальное название

A Prospective Multicenter Registry Study of Acute Kidney Injury in Critically Ill Patients

Обзор

Acute kidney injury (AKI) in critically ill patients is characterized by high incidence, delayed diagnosis and treatment, and high mortality. Early identification and precision management are key to improving prognosis. Currently, in China, the population with severe AKI faces prominent challenges, including a lack of standardized, localized specialized data, insufficient early warning and subtyping capabilities, and a shortage of high-quality evidence-based guidance for clinical decision-making. These issues constrain the application of artificial intelligence (AI) technologies in the precision diagnosis and treatment of AKI. Leveraging the Critical Care Medicine Specialty Alliance, which has been approved by the Beijing Hospital Management Center and consists of 19 tertiary hospital ICUs nationwide, this project will conduct a three-year prospective, observational registry study. The investigators plan to consecutively enroll 23,600 adult critically ill patients (with an anticipated \>3,000 AKI patients). The study will systematically collect clinical characteristics, time-series monitoring data, laboratory parameters, renal ultrasound imaging, biomarkers, and omics data, while concurrently retaining biological samples, to establish the largest multi-modal specialized disease dataset and biobank for severe AKI in China. Focusing on the entire AKI continuum of "early warning - diagnosis - phenotyping - treatment - prognosis," the study aims to: ① characterize the epidemiological features and disease burden of ICU-AKI in China; ② develop an early warning system for AKI; ③ identify AKI sub-phenotypes using machine learning and establish a precision management framework; ④ develop an intelligent decision support system for renal replacement therapy; ⑤ evaluate prognosis; and ⑥ promote medical-engineering collaborative translation. Expected outcomes include 3-5 early warning/prognostic models and one intelligent decision support system, along with applications for 3-5 invention patents and 2-3 software copyrights. The project aims to translate at least one outcome into practical application, provide high-level evidence-based support for developing national guidelines on severe AKI management tailored to China's context, and contribute to reducing the incidence and mortality of AKI.

Вмешательства

  • Другое Not applicable- observational study
    Save the blood and urine samples

Первичные конечные точки

  • Incidence of acute kidney injury during ICU admission [Срок оценки: During ICU admission, assessed up to 1 year]
Вторичные конечные точки (7)
  • Rate of complete renal recovery [Срок оценки: 7 days after AKI diagnosis]
  • ICU length of stay (ICU LOS) in AKI patients [Срок оценки: Assessed at ICU discharge, up to 1 year]
  • Total hospital length of stay (Total hospital LOS) [Срок оценки: Assessed at hospital discharge, up to 1 year]
  • In-hospital survival rate [Срок оценки: Assessed at hospital discharge, up to 1 year]
  • 28-day survival rate [Срок оценки: 28 days after AKI diagnosis]
  • RRT duration [Срок оценки: Assessed at RRT cessation or ICU discharge, up to 90 days]
  • Rate of RRT dependence [Срок оценки: Rate of RRT dependence at 28 days after AKI diagnosis]

Критерии участия

Критерии включения

  • Age ≥ 18 years;
  • Expected ICU stay ≥ 24 hours;
  • Informed consent signed.

Критерии исключения

  • End-stage renal disease (ESRD) on maintenance dialysis;
  • Post-renal transplant;
  • Pregnant women;
  • Lactating women;
  • Advanced cancer;
  • End-stage disease;
  • AKI already diagnosed prior to ICU admission;
  • Expected survival < 48 hours;
  • Refusal to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Chao Yang Hospital — Пекин

Идентификаторы

NCT: NCT07653321 · YangFan2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗