Establishment of a Perioperative Dynamic Prediction Model for Cardiac Surgery-associated Acute Kidney Injury
2026年9月9日 更新者：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.
研究概览
研究类型
观察性的
注册 (估计的)
70000
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The cohort included adult patients who underwent cardiovascular surgery from 2015 to 2025 (Beijing) and from 2022 to 2025 (branch hospital).
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The occurrence of CSA-AKI
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年1月1日
初级完成 (实际的)
2025年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年8月3日
首先提交符合 QC 标准的
2026年9月9日
首次发布 (实际的)
2026年9月10日
研究记录更新
最后更新发布 (实际的)
2026年9月10日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2025年12月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025-GSP-TS-2
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