Establishment of a Perioperative Dynamic Prediction Model for Cardiac Surgery-associated Acute Kidney Injury
9 de septiembre de 2026 actualizado por: China National Center for Cardiovascular Diseases
Cardiac surgery-associated Acute Kidney Injury (CSA-AKI) is one of the most common complications after cardiovascular Surgery, with an incidence rate as high as 30-50%.
CSA-AKI has many hazards, including significantly increasing the hospital stay of patients after surgery and greatly increasing medical costs.
Moreover, it significantly raises the short-term and long-term mortality (by 3 to 8 times) and the risk of occurrence or aggravation of chronic kidney disease (CKD) in patients after surgery.
These risks increase with the aggravation of CSA-AKI.
Therefore, early prevention and treatment throughout the perioperative period of CSA-AKI is crucial for improving prognosis.
Early prediction, especially preoperative prediction, is the prerequisite for the early prevention and treatment of CSA-AKI throughout the course.
The aim of this study is to establish a dynamic prediction model for the entire perioperative period of CSA-AKI, with the expectation of improving the prediction and diagnosis of CSA-AKI for the development and validation of a prediction model based on a multicenter retrospective cohort.
Using retrospective multimodal data of perioperative cardiovascular surgeries from hospitals such as Beijing, Central China, Yunnan and Fuwai Hospital in Shenzhen, and based on artificial intelligence technologies (such as machine learning), a CSA-AKI risk prediction model suitable for the entire perioperative period dynamics of various surgical types was constructed.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
70000
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The cohort included adult patients who underwent cardiovascular surgery from 2015 to 2025 (Beijing) and from 2022 to 2025 (branch hospital).
Descripción
Inclusion Criteria:
- 1. Age no less than 18 years old;
- 2. Patients who underwent cardiovascular surgeries at Fuwai Hospital in Beijing from 2015 to 2025 and at Fuwai Hospitals in Central China, Yunnan and Shenzhen from 2022 to 2025;
- 3. At least one blood creatinine test should be conducted within 48 hours after the operation, and at least two blood creatinine tests should be conducted within one week after the operation.
Exclusion Criteria:
- 1. Lack of preoperative baseline creatinine;
- 2. Patients who developed AKI before surgery or whose AKI did not recover: The definition of AKI follows the KDIGO 2012 guideline;
- 3. Patients with preoperative creatinine levels exceeding 354umol/L or those in CKD stage 5.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The occurrence of CSA-AKI
Periodo de tiempo: The assessment will be conducted from the end of the surgery until the 7th day after the operation
|
CSA-AKI is defined as: an increase of ≥26.5 µmol/L in serum creatinine (SCr) within 48 hours after cardiovascular surgery compared with the baseline, or an increase of ≥ 50% of the baseline value within 7 days after surgery.
|
The assessment will be conducted from the end of the surgery until the 7th day after the operation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3)
Periodo de tiempo: The assessment will be conducted from the end of the surgery until the 7th day after the operation
|
Acute kidney injury at stage 2 or stage 3 as defined by the KDIGO 2012 guidelines.AKI stage 2 is defined as:meet any of the following conditions:
AKI stage 3 is defined as: meeting any of the following conditions:
|
The assessment will be conducted from the end of the surgery until the 7th day after the operation
|
|
The occurrence of persistent acute kidney injury
Periodo de tiempo: 48 hours after the diagnosis of acute kidney injury
|
Persistent acute kidney injury is defined as acute kidney injury that persists for more than 48 hours after its initial diagnosis, based on serum creatinine and/or urine output according to KDIGO criteria.
|
48 hours after the diagnosis of acute kidney injury
|
|
Renal replacement therapy or in-hospital death
Periodo de tiempo: From the end of cardiac surgery until the date of first occurrence of renal replacement therapy or in-hospital death, whichever came first, assessed up to 1 year after cardiac surgery.
|
Receiving any form of renal replacement therapy (such as continuous renal replacement therapy, intermittent hemodialysis, etc.) or any in-hospital death caused by any reason.
|
From the end of cardiac surgery until the date of first occurrence of renal replacement therapy or in-hospital death, whichever came first, assessed up to 1 year after cardiac surgery.
|
|
CSA-AKI as defined by the AKIN standard
Periodo de tiempo: From the preoperative period to 48 hours after the operation
|
CSA-AKI as defined by AKIN: that is, the increase of serum creatinine within 48 hours is >26.5umol/L or > 50% of the baseline;
|
From the preoperative period to 48 hours after the operation
|
|
New CKD or progression of existing CKD
Periodo de tiempo: From the preoperative baseline assessment through 1 year after cardiac surgery
|
Chronic kidney disease (CKD) is defined according to the KDIGO 2024 guidelines.
CKD progression is defined as: an estimated decrease in glomerular filtration rate (eGFR) from baseline of more than 25%, or an average annual eGFR decrease rate of more than 5 ml/min/1.73m²
|
From the preoperative baseline assessment through 1 year after cardiac surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2015
Finalización primaria (Actual)
31 de diciembre de 2025
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
3 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de diciembre de 2025
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-GSP-TS-2
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