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Impact of Intraoperative Blood Pressure Components on Postoperative AKI: A Phenotype-Stratified Analysis

ConditionsPostoperative Acute Kidney InjuryIntraoperative Hypotension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLanyue Zhu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing non-cardiac surgery

Access to intraoperatively available invasive/noninvasive blood pressure monitoring data

Disqualifiers

Patients for Age < 18 yr

Patients without preoperative or postoperative creatinine records

Patients undergoing urinary surgeries

Patients with chronic kidney injury before surgery

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Postoperative AKI

KDIGO criteria for diagnosis (≥0.3 mg/dL or ≥1.5-fold increase in creatinine value)

Time frame
Within 7 days post-op
2

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%.

Time frame
preoperative period

Secondary outcomes

1

Postoperative AKD

KDIGO criteria for diagnosis (≥0.3 mg/dL or ≥1.5-fold increase in creatinine value)

Time frame
Within 8-90 days post-op
2

length of hospital stay

the interval from the end of surgery to discharge

Time frame
Through hospital discharge, an average of 1 weak
3

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

Time frame
preoperative period
4

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

Time frame
preoperative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lanyue Zhu

Lead sponsor

Zhongda Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: