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Enrolling by invitation NCT07653321

Acute Kidney Injury in Critically Ill Patients

— Observational Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Not applicable- observational study
    Save the blood and urine samples

Primary outcome measures

  • Incidence of acute kidney injury during ICU admission [Time frame: During ICU admission, assessed up to 1 year]
Secondary outcome measures (7)
  • Rate of complete renal recovery [Time frame: 7 days after AKI diagnosis]
  • ICU length of stay (ICU LOS) in AKI patients [Time frame: Assessed at ICU discharge, up to 1 year]
  • Total hospital length of stay (Total hospital LOS) [Time frame: Assessed at hospital discharge, up to 1 year]
  • In-hospital survival rate [Time frame: Assessed at hospital discharge, up to 1 year]
  • 28-day survival rate [Time frame: 28 days after AKI diagnosis]
  • RRT duration [Time frame: Assessed at RRT cessation or ICU discharge, up to 90 days]
  • Rate of RRT dependence [Time frame: Rate of RRT dependence at 28 days after AKI diagnosis]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Chao Yang Hospital — Beijing

Identifiers

NCT: NCT07653321 · YangFan2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗