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Development and Validation of a Risk Prediction Model for Cardiac Surgery-associated Acute Kidney Injury Based on the Gut-Kidney Axis, Incorporating Gut Microbiota and Their Metabolites

2026年7月28日 更新者：Peking Union Medical College Hospital
This is a single-center prospective observational cohort study enrolling adult patients scheduled for cardiac surgery. Multi-timepoint clinical indicators, stool samples for gut microbiota and metabolomics profiling and artery blood will be collected before and after surgery. We aim to construct and validate a multi-dimensional preoperative predictive model for CSA-AKI based on clinical, microbial and metabolic signatures. Meanwhile, this research will explore the potential mediating role of the gut-kidney axis in the pathogenesis of cardiac surgery-associated acute kidney injury, and provide novel mechanistic evidence for early risk stratification and intervention of CSA-AKI.

研究概览

地位

尚未招聘

条件

详细说明

Cardiac surgery-associated acute kidney injury (CSA-AKI) is one of the most common severe postoperative complications after cardiac surgery, which significantly increases the risks of prolonged hospitalization, chronic kidney disease and all-cause mortality. Current single-index risk scoring systems cannot fully predict individual CSA-AKI risk, and the underlying pathological mechanism remains incompletely clarified. Emerging evidence reveals that gut dysbiosis and altered intestinal metabolites participate in kidney injury via the gut-kidney axis, while few prospective cohort studies integrate multi-omics data to develop preoperative predictive models for CSA-AKI.

This prospective cohort study will consecutively recruit adult subjects receiving elective cardiac surgery at Peking Union Medical College Hospital. Basic demographic data, laboratory examinations, intraoperative and postoperative clinical parameters will be recorded at multiple perioperative time points. Fresh stool specimens and artery blood will be collected from all participants before surgery, 24 hours and 7 days after cardiac surgery for 16S rRNA gene sequencing and untargeted metabolomics analysis to characterize gut microbial composition and metabolite profiles.

The primary objective is to develop and internally validate a multi-dimensional predictive model combining clinical variables, gut flora biomarkers and metabolic signatures to stratify preoperative CSA-AKI risk of cardiac surgical patients. Secondary objectives include comparing the differences of intestinal microbiota and metabolites between patients with and without subsequent CSA-AKI, screening key microbial strains and differential metabolites related to postoperative renal impairment, and elucidate the molecular pathways of the gut-kidney axis mediating CSA-AKI occurrence.

All participants will receive standardized perioperative management following clinical guidelines. Subjects will be followed up until 7 days after surgery to identify CSA-AKI events defined by standardized serum creatinine criteria. The performance of the established prediction model will be evaluated by area under the receiver operating characteristic curve (AUC), calibration curve and decision curve analysis. All specimen testing and statistical analyses will be conducted following standardized omics and clinical research workflows. This study is approved by the institutional ethics committee, and written informed consent will be obtained from all enrolled patients prior to sample and data collection.

研究类型

观察性的

注册 (估计的)

182

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100730
        • Peking Union Medical College Hospital
        • 接触：

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

This single-center prospective observational cohort will consecutively enroll adult patients aged ≥18 years who receive elective cardiac surgery at Peking Union Medical College Hospital. Eligible subjects include patients undergoing valve surgery, coronary artery bypass grafting (CABG), or combined cardiac procedures.All enrolled participants will complete standardized perioperative data collection and serial stool sample and blood collection at preoperative baseline, postoperative day 1 and postoperative day 7. Subjects will be followed up until postoperative day 7 to identify CSA-AKI events based on KDIGO 2012 criteria.

描述

Inclusion Criteria:

  1. Aged 18 years or older;
  2. Scheduled for elective cardiac surgery;
  3. Surgery performed under cardiopulmonary bypass (CPB);
  4. Able to complete preoperative stool and blood sample collection independently;
  5. The patient and their family members voluntarily participate in this study, agree to the collection of preoperative stool samples, blood samples and clinical data, cooperate with follow-up visits, and sign the informed consent form.-

Exclusion Criteria:

（1) Patients with end-stage renal disease or dependence on renal replacement therapy before surgery; (2) Patients with a preoperative estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m² or severe chronic kidney disease (CKD stage 4-5); (3) Patients with a history of renal transplantation or unilateral nephrectomy; (4) Patients who received antibiotic treatment within 4 weeks before surgery; (5) Patients who took probiotic or prebiotic preparations within 4 weeks before surgery; (6) Patients with a previous history of intestinal surgery, such as colectomy and small bowel resection; (7) Patients with active inflammatory bowel disease, chronic diarrhea or constipation requiring pharmacological intervention; (8) Patients with preoperative intestinal obstruction, gastrointestinal bleeding, or those requiring fasting for more than 24 hours; (9) Patients undergoing emergency surgery (time from admission to surgery < 24 hours), or those unable to complete preoperative informed consent, dietary investigation and baseline sample collection; (10) Patients who received mechanical bowel preparation (e.g., enema) within 24 hours before surgery; (11) Patients with preoperative active infection or sepsis; (12) Patients treated with preoperative glucocorticoids or immunosuppressants (excluding routine doses); (13) Patients who died intraoperatively or within 24 hours postoperatively, or those who could not complete the evaluation of the primary outcome (postoperative 7-day acute kidney injury [AKI]); (14) Female patients who are pregnant, lactating or in menstruation; (15) Patients complicated with gastrointestinal malignant tumors or receiving systemic chemotherapy, targeted therapy or abdominal radiotherapy; (16) Patients with severe liver disease (Child-Pugh grade B or above).

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

队列和干预

团体/队列
all patients undergoing elective cardiac surgery
Consecutive adult patients scheduled for cardiac surgery. Multi-timepoint clinical data and stool samples are collected to build preoperative CSA-AKI prediction model, subgroup analysis will be performed according to postoperative AKI outcomes.

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
Predictive performance of multi-dimensional gut microbiota-metabolite model for postoperative CSA-AKI
大体时间：From preoperative sample collection to postoperative day 7 (CSA-AKI confirmation)
The primary outcome is the discriminative ability (AUC) of the combined preoperative gut microbiota and metabolomic signature model to predict cardiac surgery-associated acute kidney injury (CSA-AKI). CSA-AKI is diagnosed per KDIGO 2012 criteria: serum creatinine rises ≥0.3 mg/dL within 48h postoperatively or ≥1.5-fold baseline within 7 days after cardiac surgery. The predictive performance of the multi-omics combined model will be quantified by the area under the receiver operating characteristic curve (AUC-ROC).
From preoperative sample collection to postoperative day 7 (CSA-AKI confirmation)

次要结果测量

结果测量
措施说明
大体时间
Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) within 7 days after cardiac surgery
大体时间：7 days after cardiac surgery
CSA-AKI is diagnosed in accordance with the KDIGO 2012 AKI standard: serum creatinine increases by ≥0.3 mg/dL within 48 hours postoperatively, or serum creatinine reaches ≥1.5 times the preoperative baseline value within 7 days after cardiac surgery. The incidence rate is calculated as the proportion of patients who meet the CSA-AKI diagnostic criteria among all enrolled subjects.
7 days after cardiac surgery
Severity grading of CSA-AKI according to KDIGO 2012 staging criteria
大体时间：7 days after cardiac surgery
For subjects diagnosed with CSA-AKI within postoperative 7 days, stratify patients into KDIGO Stage 1, Stage 2 and Stage 3 based on the maximum serum creatinine elevation during follow-up, and compare the distribution of AKI severity grades in the cohort.
7 days 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。

赞助

Peking Union Medical College Hospital

调查人员

  • 首席研究员：Yu、Peking Union Medical College Hospital

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 (估计的)

2026年8月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年7月28日

首先提交符合 QC 标准的

2026年7月28日

首次发布 (实际的)

2026年7月31日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • K10744

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data (including perioperative clinical laboratory data, gut microbiota sequencing raw data, stool metabolomics and blood data, and standardized case report forms) will be shared with qualified researchers after the completion of primary study analysis and the publication of core research manuscripts. All personal identifiable information will be permanently removed to protect patient privacy in compliance with Chinese medical research ethics regulations.

IPD 共享访问标准

Data will become available 6 months after full study completion and primary manuscript publication; data access will remain available for 5 years after publication.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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