Zhongda Hospital Southeast University
Nanjing, Jiangsu Provincce, 210000, China
NCT Number: NCT07156474
Postoperative acute kidney injury (AKI) is a serious complication often linked to low blood pressure during surgery. This study aims to better protect patients' kidneys by personalizing how blood pressure is managed during an operation.
The project has two main goals:
First, researchers will analyze data from over 44,000 past surgeries to identify which specific blood pressure measurements are the most critical warning signs for kidney damage.
Second, using this knowledge, they will build a smart tool (a machine learning model) to predict a unique, safe blood pressure target for each individual patient before their surgery begins.
This personalized approach is intended to give doctors a specific target to maintain during surgery, helping to prevent kidney injury and improve patient safety.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Nanjing, Jiangsu Provincce, 210000, China
Currently, there is no clinical consensus on which component of blood pressure-such as systolic (SBP), diastolic (DBP), or mean arterial pressure (MAP)-is the most critical to monitor for preventing organ injury. Furthermore, current guidelines often recommend a universal "one-size-fits-all" threshold for hypotension (e.g., MAP < 65 mmHg). This approach fails to account for individual patient differences, such as baseline blood pressure and co-existing health conditions, which may mean that the optimal blood pressure target varies significantly from person to person.
This study aims to address these gaps by using a large, multi-center dataset to first identify the most critical blood pressure components linked to AKI and then to develop a tool that predicts a personalized, optimal blood pressure threshold for individual patients.
This study is divided into two parts:
Part 1: Risk Assessment and Blood Pressure Component Analysis
Part 2: Development of a Personalized Prediction Model
②To explore the relationship between the cumulative 5-minute lowest intraoperative blood pressure and postoperative AKI, using this relationship to refine the predictive model.
In Part 1, the research team will use unsupervised clustering methods (e.g., K-means) to group patients based on preoperative characteristics. Subsequently, multivariable logistic regression models will be used to analyze the association between intraoperative hypotension metrics and the risk of postoperative AKI/AKD within the overall cohort and across the different patient clusters.
In Part 2, machine learning algorithms, including XGBoost and Random Forest, will be employed to develop a series of predictive models. The final model will be designed to dynamically adjust a patient's hypotension threshold by iteratively calculating the AKI risk until it falls below a predefined safety level (10%). The model's performance will be rigorously evaluated using metrics such as the Area Under the Curve (AUC), and its interpretability will be assessed using SHAP (Shapley Additive Explanations) analysis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 7 days post-op
KDIGO criteria for diagnosis (≥0.3 mg/dL or ≥1.5-fold increase in creatinine value)
Time frame: preoperative period
A patient-specific blood pressure threshold predicted by a dynamic machine learning model. This threshold is identified as the blood pressure value at which the model-predicted risk of postoperative Acute Kidney Injury (AKI) falls below 10%.
Time frame: Within 8-90 days post-op
KDIGO criteria for diagnosis (≥0.3 mg/dL or ≥1.5-fold increase in creatinine value)
Time frame: Through hospital discharge, an average of 1 weak
the interval from the end of surgery to discharge
Time frame: preoperative period
The probability of developing postoperative AKI, as calculated by a machine learning model using preoperative baseline data. Measured by AUROC, AUPRC and Calibration Curve
Time frame: preoperative period
The predicted cumulative 5-minute lowest intraoperative blood pressure value, generated by a machine learning model based on preoperative data. Measured by R2 and MAE
Contact information is provided by the study sponsor or research team.
Lanyue Zhu
Other
Risk Assessment of Postoperative Acute Kidney Injury and Personalized Intraoperative Hypotension Threshold Prediction Based on Blood Pressure Components in Non-Cardiac Surgery Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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