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

NCT ID: NCT07136194

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21533 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Adult patients undergoing major surgery

Adult patients undergoing major surgery

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Yang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2023-625-002

Identifier Type: -

Identifier Source: org_study_id