Risk Factors of Postoperative Acute Kidney Injury and Mortality Among Hospitalized Patients Undergoing Major Surgery

Completed

• Conditions: Acute Kidney Injury; Major Surgery Under General Anesthesia; Mortality; Postoperative Complication; Risk Factors

• Registration Number: NCT07136194
• Lead Sponsor: Peking University First Hospital

Brief Summary

The goal of this retrospective observational study is to learn about the intervenable risk factors of postoperative acute kidney injury (AKI) and in-hospital mortality among adult patients undergoing major surgery. The main questions it aims to answer are:

1. Does preoperative usage of potential nephrotoxic medications (eg., proton pump inhibitor, non-steroidal anti-inflammatory drugs) increase the risk of postoperative AKI and in-hospital mortality?

2. Does preoperative status (eg., malnutrition, hypoalbuminemia, hypomagnesemia) increase the risk of postoperative AKI and in-hospital mortality?

3. Are there intervenable risk factors of postoperative AKI and in-hospital mortality?

4. Are there special risk factors of postoperative AKI and in-hospital mortality in specific patients (eg. elderly, diabetics)? The study will be conducted in retrospective cohort of patients undergoing major surgery. Participants are followed until discharge.

Detailed Description

Acute Kidney Injury (AKI), characterized by a rapid decline of kidney function, is a common but serious postoperative complication in surgical patients, with an incidence ranging from 5.3% to 18.4%. Postoperative AKI is associated with increased mortality, prolonged hospital stays, and higher medical costs. Survivors are also prone to developing chronic kidney disease (CKD) or even end-stage renal disease (ESRD) . Identifying intervenable risk factors of postoperative AKI can help clinicians develop targeted strategies for high-risk patients.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21533

Inclusion Criteria

• Age≥18 years
• Hospitalized at Peking University First Hospital (PKUFH) between January 1, 2018, and December 31, 2020
• Undergoing major surgery during hospital stay

Exclusion Criteria

• With fewer than two serum creatinine (SCr) measurements during hospitalization, or lack of postoperative SCr assessment
• With pre-exsiting CKD G5 (including long-term dialysis, prior/current kidney transplantation, or baseline estimated glomerular filtration rate [eGFR]<15mL/min/1.73m^2) at admission
• Undergoing radical or partial nephrectomy during current hospitalization
• Developing AKI prior to surgery or within 24 hours after admission (with admission diagnosis of AKI or meeting AKI criteria within 24 hours)
• With hospital stay < 24 hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative acute kidney injury	within 7 days after major surgery	Acute kidney injury was defined by the KDIGO criteria. Postoperative AKI referred to acute kidney injury occurring within 7 days after major surgery.

Secondary Outcome Measures

Name	Time	Method
In-hospital acute kidney injury	after major surgery until up to 1year	Acute kidney injury was defined by the KDIGO criteria. In-hospital acute kidney injury referred to acute kidney injury occurring after major surgery before discharge.
In-hospital mortality	after major surgery until up to 1 year	death during hospitalization

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China