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Enrolling by Invitation

NCT Number: NCT07653321

Acute Kidney Injury in Critically Ill Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao Yang Hospital

Beijing, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Not applicable- observational study

Other

Save the blood and urine samples

Primary outcomes

  1. Incidence of acute kidney injury during ICU admission

    Time frame: During ICU admission, assessed up to 1 year

Secondary outcomes

  1. Rate of complete renal recovery

    Time frame: 7 days after AKI diagnosis

  2. ICU length of stay (ICU LOS) in AKI patients

    Time frame: Assessed at ICU discharge, up to 1 year

  3. Total hospital length of stay (Total hospital LOS)

    Time frame: Assessed at hospital discharge, up to 1 year

  4. In-hospital survival rate

    Time frame: Assessed at hospital discharge, up to 1 year

  5. 28-day survival rate

    Time frame: 28 days after AKI diagnosis

  6. RRT duration

    Time frame: Assessed at RRT cessation or ICU discharge, up to 90 days

  7. Rate of RRT dependence

    Time frame: Rate of RRT dependence at 28 days after AKI diagnosis

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

  • Affiliated Hospital of Hebei University
  • Baoding First Central Hospital
  • Beijing Obstetrics and Gynecology Hospital
  • Beijing Shuyi Hospital
  • Cangzhou Central Hospital
  • Changzhi People's Hospital
  • General Hospital of Taiyuan Iron & Steel Company
  • Hangzhou Hospital of Traditional Chinese Medicine
  • Hebei Provincial Hospital of Traditional Chinese Medicine
  • Hengshui People's Hospital
  • Inner Mongolia Baogang Hospital
  • Jincheng People's Hospital
  • Luohe Central Hospital
  • Second Hospital of Shanxi Medical University
  • The People's Hospital of Hebei Province
  • Tianjin First Central Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • Xinxiang Central Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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