- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07653321
Acute Kidney Injury in Critically Ill Patients
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
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Beijing, China, 100020
- Beijing Chao Yang Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Incidence of acute kidney injury during ICU admission
Tijdsspanne: During ICU admission, assessed up to 1 year
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During ICU admission, assessed up to 1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Rate of complete renal recovery
Tijdsspanne: 7 days after AKI diagnosis
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7 days after AKI diagnosis
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ICU length of stay (ICU LOS) in AKI patients
Tijdsspanne: Assessed at ICU discharge, up to 1 year
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Assessed at ICU discharge, up to 1 year
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Total hospital length of stay (Total hospital LOS)
Tijdsspanne: Assessed at hospital discharge, up to 1 year
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Assessed at hospital discharge, up to 1 year
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In-hospital survival rate
Tijdsspanne: Assessed at hospital discharge, up to 1 year
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Assessed at hospital discharge, up to 1 year
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28-day survival rate
Tijdsspanne: 28 days after AKI diagnosis
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28 days after AKI diagnosis
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RRT duration
Tijdsspanne: Assessed at RRT cessation or ICU discharge, up to 90 days
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Assessed at RRT cessation or ICU discharge, up to 90 days
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Rate of RRT dependence
Tijdsspanne: Rate of RRT dependence at 28 days after AKI diagnosis
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Rate of RRT dependence at 28 days after AKI diagnosis
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- YangFan2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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