Acute Kidney InjuryNCT07653321
Acute Kidney Injury in Critically Ill Patients
An observational study of Acute Kidney Injury, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Not applicable- observational study
- How many people
- 23,600 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2029
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AKI diagnosed during ICU stay
Who may be able to join
- Age ≥ 18 years;
- Expected ICU stay ≥ 24 hours;
- Informed consent signed.
Who cannot join
- End-stage renal disease (ESRD) on maintenance dialysis;
- Post-renal transplant;
- Pregnant women;
- Lactating women;
- Advanced cancer;
- End-stage disease;
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- AKI already diagnosed prior to ICU admission;
- Expected survival < 48 hours;
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Not applicable- observational study
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Save the blood and urine samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury during ICU admission
Measured: During ICU admission, assessed up to 1 year
Secondary outcomes (7)
Rate of complete renal recovery
Measured: 7 days after AKI diagnosis
ICU length of stay (ICU LOS) in AKI patients
Measured: Assessed at ICU discharge, up to 1 year
Total hospital length of stay (Total hospital LOS)
Measured: Assessed at hospital discharge, up to 1 year
In-hospital survival rate
Measured: Assessed at hospital discharge, up to 1 year
28-day survival rate
Measured: 28 days after AKI diagnosis
RRT duration
Measured: Assessed at RRT cessation or ICU discharge, up to 90 days
Rate of RRT dependence
Measured: Rate of RRT dependence at 28 days after AKI diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 May 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,600 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The People's Hospital of Hebei Province, Tianjin First Central Hospital, Second Hospital of Shanxi Medical University, Beijing Obstetrics and Gynecology Hospital, Affiliated Hospital of Hebei University, Hebei Provincial Hospital of Traditional Chinese Medicine, Hangzhou Hospital of Traditional Chinese Medicine, Baoding First Central Hospital, Beijing Shuyi Hospital, Cangzhou Central Hospital, Hengshui People's Hospital, Sixth Hospital of Shanxi Medical University, Changzhi People's Hospital, Jincheng People's Hospital, Xinxiang Central Hospital, Luohe Central Hospital, Inner Mongolia Baogang Hospital, Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653321
- Sponsor's protocol ID
- YangFan2026
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the restrictions of the informed consent form / ethical approval, IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Registry Study of Acute Kidney Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07653321
- Acronym / sponsor ID
- YangFan2026
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 23,600 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- The People's Hospital of Hebei Province, Tianjin First Central Hospital, Second Hospital of Shanxi Medical University, Beijing Obstetrics and Gynecology Hospital, Affiliated Hospital of Hebei University, Hebei Provincial Hospital of Traditional Chinese Medicine, Hangzhou Hospital of Traditional Chinese Medicine, Baoding First Central Hospital, Beijing Shuyi Hospital, Cangzhou Central Hospital, Hengshui People's Hospital, Sixth Hospital of Shanxi Medical University, Changzhi People's Hospital, Jincheng People's Hospital, Xinxiang Central Hospital, Luohe Central Hospital, Inner Mongolia Baogang Hospital, Tianjin Medical University Cancer Institute and Hospital
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AKI diagnosed during ICU stay
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Expected ICU stay ≥ 24 hours;
- Informed consent signed.
Key exclusion criteria (9 listed)
- End-stage renal disease (ESRD) on maintenance dialysis;
- Post-renal transplant;
- Pregnant women;
- Lactating women;
- Advanced cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studySave the blood and urine samples | Other | – |
Primary outcome
Incidence of acute kidney injury during ICU admission
Time frame: During ICU admission, assessed up to 1 year
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Due to the restrictions of the informed consent form / ethical approval, IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury during ICU admission (time frame: During ICU admission, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.