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OpenTrials
Completed

NCT Number: NCT07136194

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative acute kidney injury

    Time frame: 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

  1. In-hospital acute kidney injury

    Time frame: 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.

  2. In-hospital mortality

    Time frame: after major surgery until up to 1 year

    death during hospitalization

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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