Acute Kidney Injury in Critically Ill Patients

A Prospective Multicenter Registry Study of 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Not applicable- observational study

• Study Type: Observational
• Enrollment (Estimated): 23600

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100020
    • Beijing Chao Yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with AKI diagnosed during ICU stay

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. Expected ICU stay ≥ 24 hours;
3. Informed consent signed.

Exclusion Criteria:

1. End-stage renal disease (ESRD) on maintenance dialysis;
2. Post-renal transplant;
3. Pregnant women;
4. Lactating women;
5. Advanced cancer;
6. End-stage disease;
7. AKI already diagnosed prior to ICU admission;
8. Expected survival < 48 hours;
9. Refusal to participate in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of acute kidney injury during ICU admission	During ICU admission, assessed up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of complete renal recovery	7 days after AKI diagnosis
ICU length of stay (ICU LOS) in AKI patients	Assessed at ICU discharge, up to 1 year
Total hospital length of stay (Total hospital LOS)	Assessed at hospital discharge, up to 1 year
In-hospital survival rate	Assessed at hospital discharge, up to 1 year
28-day survival rate	28 days after AKI diagnosis
RRT duration	Assessed at RRT cessation or ICU discharge, up to 90 days
Rate of RRT dependence	Rate of RRT dependence at 28 days after AKI diagnosis

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: YangFan2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the restrictions of the informed consent form / ethical approval, IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No