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临床试验/NCT05533619
NCT05533619已完成不适用

Analysis of Risk Factors of Proton Pump Inhibitor Related Acute Kidney Injury in Hospitalized Patients and Developments of Machine Learning Model

Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30,000
试验地点
1
主要终点
The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors

研究概览

简要总结

Recent evidence concerns acute kidney injury (AKI) following proton pump inhibitor (PPI) application. Few actual studies have compared the incidence, risk factors, and predictive models of AKI associated with PPI. The present study was a single-center retrospective study. The researchers retrospectively analyzed data from patients who received PPI medications between January 2018 and December 2020. PPI drugs included omeprazole, esomeprazole, rabeprazole, and pantoprazole. The primary outcome of the study was AKI, as defined by kidney disease: improving global outcomes (KDIGO). Secondary outcomes included length of hospital stay, hospital costs, and continuous renal replacement therapy. Independent risk factors associated with AKI were identified by univariate analysis and multifactorial logistic regression analysis (P < 0.05). Logistic regression models were constructed based on the variables obtained from the analysis. Internal validation of the model was performed by the ten-fold cross-validation method. Model discriminatory power was assessed by the area under the curve (AUC) of the receiver operating characteristic curve (ROC). The study aims to develop a PPI-related AKI prediction model based on an electronic medical record system that can be used to predict AKI in hospitalized patients and contribute to the early prevention, diagnosis and treatment of AKI, ultimately reducing morbidity and improving prognosis.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All inpatients who used proton pump inhibitor during hospitalization
  • Hospital stay ≥ 48h
  • Age ≥18 years
  • There are two or more blood creatinine tests during hospitalization

排除标准

  • Hospital stay < 48h
  • Age <18 years
  • Glomerular filtration rate (GFR)< 30ml/min/1.73m2 within 48 hours after admission
  • AKI was diagnosed on admission
  • Less than two Scr test results during hospitalization
  • The Scr values were always lower than 40 μmol/L during hospitalization
  • Cases with incomplete medical history information

研究组 & 干预措施

AKI Group

干预措施: Proton pump inhibitor (Drug)

Non-AKI Group

干预措施: Proton pump inhibitor (Drug)

结局指标

主要结局

The incidence of acute kidney injury in hospitalized patients treated with proton pump inhibitors

时间窗: Through study completion,up to half a year.

To analyze the incidence of acute kidney injury in hospitalized patients after using proton pump inhibitors, and to build a prediction model. To assess the risk factors before using proton pump inhibitors is helpful to the early prevention, diagnosis and treatment of AKI.

次要结局

未报告次要终点

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiao Li,MD

Associate professor of pharmacy

Qianfoshan Hospital

研究点 (1)

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