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临床试验/NCT07136194
NCT07136194已完成不适用

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

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 21,533 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21,533
试验地点
1
主要终点
Postoperative acute kidney injury

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Postoperative acute kidney injury

时间窗: 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.

次要结局

  • In-hospital acute kidney injury(after major surgery until up to 1year)
  • In-hospital mortality(after major surgery until up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Yang

Professor

Peking University First Hospital

研究点 (1)

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