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Acute Kidney Injury in Critically Ill Patients

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07653321
Enrollment
23600
Registered
2026-06-17
Start date
2026-05-01
Completion date
2029-05-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

Interventions

OTHERNot applicable- observational study

Save the blood and urine samples

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of acute kidney injury during ICU admissionDuring ICU admission, assessed up to 1 year

Secondary

MeasureTime frame
Rate of complete renal recovery7 days after AKI diagnosis
ICU length of stay (ICU LOS) in AKI patientsAssessed 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 rateAssessed at hospital discharge, up to 1 year
28-day survival rate28 days after AKI diagnosis
RRT durationAssessed at RRT cessation or ICU discharge, up to 90 days
Rate of RRT dependenceRate of RRT dependence at 28 days after AKI diagnosis

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026