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

NCT07136194 — Completed, 21533 participants, Peking University First Hospital

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Registry	NCT07136194
Status	Completed
Study type	Observational
Enrollment	21533 (Actual)
Sponsor	Peking University First Hospital (Other)
Conditions	Acute Kidney Injury, Major Surgery Under General Anesthesia, Mortality, Postoperative Complication, Risk Factors
Dates	start 2018-01-01, primary completion 2020-12-31, completion 2020-12-31, first posted 2025-08-22, last updated 2025-08-22
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Adult patients undergoing major surgery			Adult patients undergoing major surgery

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 99 Years

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

+Locations (1)

Facility	City	Country	Status
Peking University First Hospital	Beijing, Beijing Municipality	China

+Investigators

Li Yang, Doctor, Principal investigator, Peking University First Hospital