- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
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Beijing, Kina, 100020
- Beijing Chao Yang Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of acute kidney injury during ICU admission
Tidsramme: During ICU admission, assessed up to 1 year
|
During ICU admission, assessed up to 1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Rate of complete renal recovery
Tidsramme: 7 days after AKI diagnosis
|
7 days after AKI diagnosis
|
|
ICU length of stay (ICU LOS) in AKI patients
Tidsramme: Assessed at ICU discharge, up to 1 year
|
Assessed at ICU discharge, up to 1 year
|
|
Total hospital length of stay (Total hospital LOS)
Tidsramme: Assessed at hospital discharge, up to 1 year
|
Assessed at hospital discharge, up to 1 year
|
|
In-hospital survival rate
Tidsramme: Assessed at hospital discharge, up to 1 year
|
Assessed at hospital discharge, up to 1 year
|
|
28-day survival rate
Tidsramme: 28 days after AKI diagnosis
|
28 days after AKI diagnosis
|
|
RRT duration
Tidsramme: Assessed at RRT cessation or ICU discharge, up to 90 days
|
Assessed at RRT cessation or ICU discharge, up to 90 days
|
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Rate of RRT dependence
Tidsramme: Rate of RRT dependence at 28 days after AKI diagnosis
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Rate of RRT dependence at 28 days after AKI diagnosis
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- YangFan2026
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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