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临床试验/NCT02793167
NCT02793167已完成不适用

Clinical Values of Automated Electronic Alert for Acute Kidney injury-a Prospective ,Randomly Controlled Cohort Study

XinLing Liang1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,000
试验地点
1
主要终点
Adverse events during hospitalization

研究概览

简要总结

Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of AKI by early detection and timely referral to the renal,the investigators developed an electronic alert system which identifies all cases of AKI occurring in patients over 18 years.The system was also designed to collect data on AKI incidence one of the biggest tertiary hospital in China.

详细描述

A prospective, randomly controlled cohort study will be conducted agmong the patients with AKI who are detected by the use of AKI sniffer. The investigators chose to assess all inpatient serum creatinine results using a combination of "KDIGO" criteria.

The investigators randomly divided the patients into two groups:

  1. Usual care : patients will receive standard clinical care by the primary physicians
  2. AKI alert : an AKI alert will be sent to the the doctor in charge. Our team of kidney experts would give a suggestion if the the doctor in charge issue consultation applications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

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

  • adult patients with an Alert for AKI(based on KDIGO guidelines)

排除标准

  • patients already on dialysis for AKI at the time of alert
  • patients with End stage renal disease
  • patients <18 years of age
  • patients dissenting from participation according to the Ethics application

结局指标

主要结局

Adverse events during hospitalization

时间窗: from start of AKI to discharge,up to 4 weeks

cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death

Incidence of cardiovascular disease and its occurrence time followed up for 1 years

时间窗: One year after discharge

heart failure/ acute coronary syndrome/ readmission/cardiac readmission/ cardiovascular intervention or surgery

AKI recovery/stop renal replacement therapy

时间窗: from start of AKI to discharge,up to 4 weeks

Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation

The AKI outcome and its occurrence time followed up for 1 years

时间窗: One year after discharge

AKI recovery/stop renal replacement therapy

次要结局

  • Follow-up rate after discharge(One year after discharge)
  • Proportion of nephrology referral(from start of AKI to discharge,up to 4 weeks)
  • Diagnostic rate of AKI at discharge(from start of AKI to discharge,up to 4 weeks)

研究者

发起方
XinLing Liang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

XinLing Liang

Director of Blood Purification Center of Guangdong General Hospital

Guangdong Provincial People's Hospital

研究点 (1)

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