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临床试验/NCT05533593
NCT05533593已完成不适用

Analysis of Risk Factors of Aminoglycines Related Acute Kidney Injury in Hospitalized Patients and Development of Machine Learning Model

Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 8,000 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
8,000
试验地点
1
主要终点
The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides

研究概览

简要总结

Drug-induced acute kidney injury (D-AKI) can occur after treatment with aminoglycosides. Predicting the risk of D-AKI is important for a tailored prevention and palliation strategy. There are currently no studies to construct a model for predicting the risk of D-AKI associated with aminoglycosides. Therefore, the study aimed to develop a model to predict the risk of D-AKI that could be used in clinical practice. Clinical data of inpatients treated with aminoglycosides at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020, were collected. The primary endpoint was D-AKI, defined according to the 2012 Global Outcomes for Kidney Disease Improvement (KDIGO). Patient clinical information, including demographic information, admission and discharge information, disease history, medication information, and laboratory tests, was obtained through an in-hospital electronic medical record system. Independent risk factors associated with D-AKI will be screened by univariate and multifactorial analyses. Covariates with significant differences (P < 0.05) were included in logistic regression models. The models were evaluated by the area under the curve (AUC) of the receiver operating characteristic curve (ROC) obtained by ten-fold cross-validation. Future studies are needed to test the application of this model in clinical practice to determine whether D-AKI in this setting can be predicted and mitigated.

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
否

入选标准

  • •All inpatients who used aminoglycosides 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: Aminoglycoside (Drug)

Non-AKI Group

干预措施: Aminoglycoside (Drug)

结局指标

主要结局

The incidence of acute kidney injury in hospitalized patients treated with aminoglycosides

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

To analyze the incidence of acute kidney injury in hospitalized patients after using aminoglycosides and to build a prediction model.

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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