- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana, 100020
- Beijing Chao Yang Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence of acute kidney injury during ICU admission
Periodo de tiempo: During ICU admission, assessed up to 1 year
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During ICU admission, assessed up to 1 year
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Rate of complete renal recovery
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 28 days after AKI diagnosis
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28 days after AKI diagnosis
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RRT duration
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- YangFan2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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