Acute Kidney Injury in Critically Ill Patients

NCT07653321 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 23600

Last updated 2026-06-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Not applicable- observational study

Save the blood and urine samples

Sponsors & Collaborators

  • The People's Hospital of Hebei Province

    collaborator OTHER
  • Tianjin First Central Hospital

    collaborator OTHER
  • Second Hospital of Shanxi Medical University

    collaborator OTHER
  • Beijing Obstetrics and Gynecology Hospital

    collaborator OTHER
  • Affiliated Hospital of Hebei University

    collaborator OTHER
  • Hebei Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER_GOV
  • Hangzhou Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Baoding First Central Hospital

    collaborator OTHER
  • Beijing Shuyi Hospital

    collaborator OTHER
  • Cangzhou Central Hospital

    collaborator OTHER
  • Hengshui People's Hospital

    collaborator OTHER
  • General Hospital of Taiyuan Iron & Steel Company

    collaborator UNKNOWN
  • Changzhi People's Hospital

    collaborator OTHER
  • Jincheng People's Hospital

    collaborator OTHER
  • Xinxiang Central Hospital

    collaborator OTHER
  • Luohe Central Hospital

    collaborator OTHER
  • Inner Mongolia Baogang Hospital

    collaborator OTHER
  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER
  • Beijing Chao Yang Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-05-01
Completion
2029-05-01

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07653321 on ClinicalTrials.gov