By InvitationNot Applicable

Acute Kidney Injury in Critically Ill Patients

China23,600 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is enrolling by invitation only, can you tell me whether I or my loved one would even be considered for participation, and what criteria the ICU team uses to extend an invitation?
2This study is measuring how often acute kidney injury occurs during ICU admission — does that mean it's mainly observational, and if so, would participating change anything about the actual treatment my loved one receives?
3Because this trial doesn't have a listed phase, it may be focused on tracking and understanding AKI rather than testing a new treatment — can you explain what the research team would actually be doing with my loved one's data, and how that benefits patients like us?
4Given that this trial takes place in the ICU setting, what does participation involve practically — are there extra blood draws, monitoring procedures, or other demands on a critically ill patient or their family?
5Are there standard clinical protocols already in place at this hospital for preventing or managing acute kidney injury in ICU patients, and would being in this study affect access to any of those standard-of-care options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of acute kidney injury during ICU admission

Timeframe: During ICU admission, assessed up to 1 year

Trial details

NCT IDNCT07653321

SponsorBeijing Chao Yang Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-05-01

View on ClinicalTrials.gov More Acute Kidney Injury trials