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

NCT07156474 | Not Yet Recruiting

• 1 other identifier: 2025ZDSYLL282
• Study Type: observational
• Target: 44,504
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Acute Kidney Injury; Intraoperative Hypotension

Outcome Measures

Primary Outcomes (2)

• Postoperative AKI

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

  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%.

  preoperative period

Secondary Outcomes (4)

• Postoperative AKD

  Within 8-90 days post-op

• length of hospital stay

  Through hospital discharge, an average of 1 weak

• Predicted Risk of Postoperative AKI.

  preoperative period

• Predicted Lowest Intraoperative Blood Pressure.

  preoperative period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients undergoing non-cardiac surgery
• Access to intraoperatively available invasive/noninvasive blood pressure monitoring data

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lanyue Zhu: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu Provincce, 210000, China

Location

Central Study Contacts

Ran You Wang

CONTACT

+8617696539413; wyr38110@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

CN (1)