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

NCT07136194 | Completed

• 1 other identifier: 2023-625-002
• Study Type: observational
• Target: 21,533
• Locations: 1 country
• Sites: 1

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. 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. 2.Does preoperative status (eg., malnutrition, hypoalbuminemia, hypomagnesemia) increase the risk of postoperative AKI and in-hospital mortality?
3. 3.Are there intervenable risk factors of postoperative AKI and in-hospital mortality?
4. 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.

Conditions

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

Keywords

acute kidney injury; major surgery; mortality

Outcome Measures

Primary Outcomes (1)

• Postoperative acute kidney injury

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

  within 7 days after major surgery

Secondary Outcomes (2)

• In-hospital acute kidney injury

  after major surgery until up to 1year

• In-hospital mortality

  after major surgery until up to 1 year

Study Arms (1)

Adult patients undergoing major surgery

Adult patients undergoing major surgery

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive hospitalized adult patients (≥18 years) undergoing major surgery at Peking University First Hospital (PKUFH) between January 1, 2018, and December 31, 2020.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Acute Kidney Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Yang, Doctor

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 22, 2025
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)