Postoperative Acute Kidney InjuryNCT07156474
Impact of Intraoperative Blood Pressure Components on Postoperative AKI: A Phenotype-Stratified Analysis
An observational study of Postoperative Acute Kidney Injury and Intraoperative Hypotension, run by Lanyue Zhu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Acute Kidney Injury, Intraoperative Hypotension
- How many people
- 44,504 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All non-cardiac surgery data from INSPIRE database and all non-cardiac surgery data from 2013-2024 in Zhongda Hospital Southeast University, 2016-2024 in Nanjing First Hospital and 2013-2023 in Anhui Medical University Affiliated First Hospital were selected.
Who may be able to join
- Patients undergoing non-cardiac surgery
- Access to intraoperatively available invasive/noninvasive blood pressure monitoring data
Who cannot join
- Patients for Age < 18 yr
- Patients without preoperative or postoperative creatinine records
- Patients undergoing urinary surgeries
- Patients with chronic kidney injury before surgery
- ASA grade > 5 class
- Anesthesia duration < 60 min
Show all 9Show fewer
- Patients for non-available lowest blood pressure data during surgery
- Hemodynamic records loss more than 25% of the total anesthesia duration
- Patients for categorical variables records missing
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital Southeast University
Nanjing, Jiangsu Provincce, 210000
About this study
Official title: Risk Assessment of Postoperative Acute Kidney Injury and Personalized Intraoperative Hypotension Threshold Prediction Based on Blood Pressure Components in Non-Cardiac Surgery Patients
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:
Read more
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.
Read the detailed description
- Study Rationale Postoperative Acute Kidney Injury (AKI) is a common and severe complication following non-cardiac surgery, leading to prolonged hospital stays, increased medical costs, and a higher risk of persistent kidney failure or death. Intraoperative hypotension (abnormally low blood pressure during surgery) is recognized as a significant contributor to AKI, as it can reduce blood flow and oxygen supply to the kidneys. 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.
- Study Objectives
This study is divided into two parts:
Part 1: Risk Assessment and Blood Pressure Component Analysis
- Primary Objective: To evaluate the association between different intraoperative blood pressure components (SBP, DBP, MAP) and the incidence of postoperative AKI in distinct patient subgroups, which will be identified by clustering patients based on their preoperative baseline characteristics.
- Secondary Objective: To assess the association between these blood pressure components and the incidence of postoperative Acute Kidney Disease (AKD), a condition of longer-duration kidney damage.
Part 2: Development of a Personalized Prediction Model
- Primary Objective: To develop and validate a dynamic machine learning model that provides an individualized prediction of the optimal intraoperative hypotension threshold for patients undergoing non-cardiac surgery.
- Secondary Objectives:
- To build a machine learning model that predicts a patient's risk of developing postoperative AKI based on their preoperative data. ②To explore the relationship between the cumulative 5-minute lowest intraoperative blood pressure and postoperative AKI, using this relationship to refine the predictive model.
- Study Design and Methods This is a retrospective, multi-center cohort study.
- Data Sources: The study will utilize de-identified electronic health record data from several large sources: the public INSPIRE database, Zhongda Hospital affiliated with Southeast University (2013-2024), Nanjing First Hospital (2016-2024), and the First Affiliated Hospital of Anhui Medical University (2013-2023).
- Study Population: The study will include adult patients (age ≥ 18) who underwent non-cardiac surgery and had available intraoperative blood pressure monitoring data. An initial dataset of approximately 850,000 surgical records will be screened, with an estimated final cohort of 44,504 eligible patients after applying inclusion and exclusion criteria. Key exclusions include patients with pre-existing severe chronic kidney disease, those undergoing urological or kidney-related surgeries, and procedures with a short duration of anesthesia (<60 min).
- Analysis Plan:
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative AKI
KDIGO criteria for diagnosis (≥0.3 mg/dL or ≥1.5-fold increase in creatinine value)
Measured: Within 7 days post-op
Individualized Optimal Intraoperative Hypotension Threshold.
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%.
Measured: preoperative period
Secondary outcomes (4)
Postoperative AKD
KDIGO criteria for diagnosis (≥0.3 mg/dL or ≥1.5-fold increase in creatinine value)
Measured: Within 8-90 days post-op
length of hospital stay
the interval from the end of surgery to discharge
Measured: Through hospital discharge, an average of 1 weak
Predicted Risk of Postoperative AKI.
The probability of developing postoperative AKI, as calculated by a machine learning model using preoperative baseline data. Measured by AUROC, AUPRC and Calibration Curve
Measured: preoperative period
Predicted Lowest Intraoperative Blood Pressure.
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
Measured: preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start9 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44,504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanyue Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lanyue Zhu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156474
- Sponsor's protocol ID
- 2025ZDSYLL282
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment of Postoperative Acute Kidney Injury and Personalized Intraoperative Hypotension Threshold Prediction Based on Blood Pressure Components in Non-Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07156474
- Acronym / sponsor ID
- 2025ZDSYLL282
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 44,504 participants (estimated)
- Lead sponsor
- Lanyue ZhuUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study Rationale Postoperative Acute Kidney Injury (AKI) is a common and severe complication following non-cardiac surgery, leading to prolonged hospital stays, increased medical costs, and a higher risk of persistent kidney failure or death. Intraoperative hypotension (abnormally low blood pressure during surgery) is recognized as a significant contributor to AKI, as it can reduce blood flow and oxygen supply to the kidneys. 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.
- Study Objectives
This study is divided into two parts:
Part 1: Risk Assessment and Blood Pressure Component Analysis
- Primary Objective: To evaluate the association between different intraoperative blood pressure components (SBP, DBP, MAP) and the incidence of postoperative AKI in distinct patient subgroups, which will be identified by clustering patients based on their preoperative baseline characteristics.
- Secondary Objective: To assess the association between these blood pressure components and the incidence of postoperative Acute Kidney Disease (AKD), a condition of longer-duration kidney damage.
Part 2: Development of a Personalized Prediction Model
- Primary Objective: To develop and validate a dynamic machine learning model that provides an individualized prediction of the optimal intraoperative hypotension threshold for patients undergoing non-cardiac surgery.
- Secondary Objectives:
- To build a machine learning model that predicts a patient's risk of developing postoperative AKI based on their preoperative data. ②To explore the relationship between the cumulative 5-minute lowest intraoperative blood pressure and postoperative AKI, using this relationship to refine the predictive model.
- Study Design and Methods This is a retrospective, multi-center cohort study.
- Data Sources: The study will utilize de-identified electronic health record data from several large sources: the public INSPIRE database, Zhongda Hospital affiliated with Southeast University (2013-2024), Nanjing First Hospital (2016-2024), and the First Affiliated Hospital of Anhui Medical University (2013-2023).
- Study Population: The study will include adult patients (age ≥ 18) who underwent non-cardiac surgery and had available intraoperative blood pressure monitoring data. An initial dataset of approximately 850,000 surgical records will be screened, with an estimated final cohort of 44,504 eligible patients after applying inclusion and exclusion criteria. Key exclusions include patients with pre-existing severe chronic kidney disease, those undergoing urological or kidney-related surgeries, and procedures with a short duration of anesthesia (<60 min).
- Analysis Plan:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All non-cardiac surgery data from INSPIRE database and all non-cardiac surgery data from 2013-2024 in Zhongda Hospital Southeast University, 2016-2024 in Nanjing First Hospital and 2013-2023 in Anhui Medical University Affiliated First Hospital were selected.
Key inclusion criteria (2 listed)
- Patients undergoing non-cardiac surgery
- Access to intraoperatively available invasive/noninvasive blood pressure monitoring data
Key exclusion criteria (9 listed)
- Patients for Age < 18 yr
- Patients without preoperative or postoperative creatinine records
- Patients undergoing urinary surgeries
- Patients with chronic kidney injury before surgery
- ASA grade > 5 class
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative AKI
Time frame: Within 7 days post-op
KDIGO criteria for diagnosis (≥0.3 mg/dL or ≥1.5-fold increase in creatinine value)
Individualized Optimal Intraoperative Hypotension Threshold.
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%.
4 secondary outcomes
Postoperative AKD
Time frame: Within 8-90 days post-op
length of hospital stay
Time frame: Through hospital discharge, an average of 1 weak
Predicted Risk of Postoperative AKI.
Time frame: preoperative period
Predicted Lowest Intraoperative Blood Pressure.
Time frame: preoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Acute Kidney Injury and Intraoperative Hypotension, run by Lanyue Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative AKI (time frame: Within 7 days post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.