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临床试验/NCT03754023
NCT03754023已完成不适用

The Potential Role of Biomarkers (Urine TIMP-IGFBP7) in Determining the Incidence of Acute Kidney Injury (AKI) in All-comers Patients Presenting to the Emergency Department With Acute Diseases

GREAT Network Italy5 个研究点 分布在 5 个国家目标入组 818 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
818
试验地点
5
主要终点
Diagnostic performance of urine TIMP-IGFBP7 as early biomarker in ruling in or ruling out acute kidney damage in patients presenting to ED with acute diseases.

研究概览

简要总结

The presence or development of AKI impacts on outcomes in patients presenting with acute conditions to the ED. As a result, treating physicians are often concerned with the risk of AKI and take such risk in consideration when making subsequent therapeutic and diagnostic decisions which may result in delaying or withholding therapeutic measures in order to prevent further kidney damage (i.e. avoid imaging studies with contrast media).

If clinicians could be informed early that a patient is at minimal risk for AKI, they could deploy timely and optimal diagnostic and treatment procedures for the underlying disease of the patient without major concerns for causing or exacerbating kidney damage

详细描述

In patients with acute diseases, it is mandatory for ED Physicians to immediately detect the presence of AKI or exclude; but unfortunately Serum creatinine (SCr) variations (based on KDIGO or AKIN criteria), take 24 to 48 hours to manifest the presence of acute renal ongoing damage. AKI is currently, infact, defined as an increase in SCr of 1.5-fold from baseline within 24 to 48 hours, and decrease in diuresis from admission in hospitalization, using KDIGO.

As consequence, similarly to other biomarkers, such as troponins in acute coronary syndrome and D-dimer in pulmonary embolism, a laboratory test to rule in or rule out AKI is needed in critical patients in ED and our primary objective would be to evaluate the role of urine TIMP-IGFBP7 in this setting.

Primary Objective of the BRAVA Study would be to evaluate the role of the urine biomarkers TIMP-IGFBP7 in predicting the occurrence of AKI in patients presenting to ED with different acute diseases and need for hospitalization.

研究设计

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

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic performance of urine TIMP-IGFBP7 as early biomarker in ruling in or ruling out acute kidney damage in patients presenting to ED with acute diseases.

时间窗: 48 hours

次要结局

  • Overall length in days of hospital stay(30 hours)
  • Regional (different countries in Asia Pacific Region) incidence of AKI in a cohort of patients presenting to the ED with acute diseases(48 hours)
  • Incidence of chronic kidney disease (CKD)(30 days)
  • Overall mortality(30 days)

研究者

发起方
GREAT Network Italy
申办方类型
Network
责任方
Sponsor

研究点 (5)

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