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临床试验/NCT04923750
NCT04923750已完成不适用

Acute Kidney Injury and Drug-related Acute Kidney Injury : Use of Hospital Coding Data for Their Identification

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2021年6月3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
498
试验地点
1
主要终点
identification of AKIs by codes in the PMSI database

研究概览

简要总结

AKI is a rapid and usually reversible impairment of kidney function that is life-threatening in the short term well described by the "Kidney Disease: Improving Global Outcomes - KDIGO" classification of 2012. Whatever etiology of acute renal failure, drug iatrogeny still has its place. Hospital data from the information systems medicalization program (PMSI) can be used for epidemiological research. No study has yet been performed on these data to assess drug-related AKI. However, it should be remembered that these databases were not originally designed for research purposes but for reimbursement of care. Therefore, before conducting a large-scale study, it remains important to determine the validity and representativeness of the codes used for coding the studied events. The objective of this project is therefore to validate the use of hospital coding to identify AKI.

详细描述

Acute kidney injury (AKI) is a rapid and usually reversible impairment of kidney function that is life-threatening in the short term; the grades of which are defined by the KDIGO classification of 2012. Whatever etiology of acute renal failure, drug iatrogeny still has its place. Data literature indicate that AKI affects more than one in five adults worldwide while hospitalized, with an associated mortality rate above 20%. It constitutes a non-negligible part of hospitalizations when it is acquired in the community, and also causes prolongations of hospitalizations, and therefore an increase in the cost for the hospital. Hospital data from the information systems medicalization program (PMSI) is a device that is part of the reform of the French health system with the aim of reducing inequalities in resources between health establishments. Since 2007, it has been possible to link all discharge summaries for one patient. The diagnoses identified during hospitalization are coded according to the 10th edition of the International Classification of Diseases (ICD-10). The data from PMSI coding can be used for epidemiological research. The majority of studies were related to patients with chronic kidney disease, especially dialysis patients. No study has yet been performed on these data to assess drug-related AKI. However, it should be remembered that these databases were not originally designed for research purposes but for reimbursement of care. Therefore, before conducting a large-scale study, it remains important to determine the validity and representativeness of the codes used for coding the events to be studied.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients over > = 18 years old
  • Patients hospitalized at the CHU Amiens Picardie during 6 months
  • patients for which at least two plasma creatinine measurements were taken during the hospitalization

排除标准

  • Patients under <18 years old
  • Patients on dialysis for chronic renal failure
  • Hospitalization for a kidney transplant
  • Postpartum AKI

结局指标

主要结局

identification of AKIs by codes in the PMSI database

时间窗: two years

identification of drug-induced AKIs by codes in the PMSI database

时间窗: two years

次要结局

  • Variation of performance of the codes according to KDIGO grade(two years)
  • incidence of drug-induced AKI(two years)
  • Identification of AKI Risk factors(two years)
  • Variation of performance of the codes according to the characteristics of the AKI(two years)
  • Variation of performance of the codes according to hospitalization service(two years)
  • Identification of the type of drugs involved in drug-induced AKI(two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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