Acute Kidney Injury in Critically Ill Patients

NCT07653321 | Enrolling By Invitation DMC

• 1 other identifier: YangFan2026
• Study Type: observational
• Target: 23,600
• Locations: 1 country
• Sites: 1

Brief 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

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of acute kidney injury during ICU admission

  During ICU admission, assessed up to 1 year

Secondary Outcomes (7)

• 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

Interventions

Not applicable- observational study OTHER

Save the blood and urine samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with AKI diagnosed during ICU stay

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, 100020, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)