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临床试验/NCT02016053
NCT02016053已完成不适用

Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
450
试验地点
1
主要终点
The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis

研究概览

简要总结

500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled

排除标准

  • Age < 18 or > 70 years
  • Preexisting Chronic Renal Disease
  • Patients with obstructive uropathy.
  • Cirrhosis with HCC (HepatoCellular Carcinoma).
  • Advanced cardiopulmonary disease
  • Pregnancy
  • Patients with extrahepatic malignancy

结局指标

主要结局

The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis

时间窗: 1 Year

Incidence is defined as No. of AKI (Acute Kidney Injury) patients during the follow up period of 1 year. Spectrum is defined as Grading of AKIN (Acute Kidney Injury Network) 1,2,3 in different child status (Child A,Child B and Child C) at the end . Natural History is defined as Occurrence of AKI (Acute Kidney Injury) and its recovery during the follow up period of 1 year.

次要结局

  • To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury(1 Years)
  • To study predictive value of Cystatin C in comparison to serum creatinine as early predictor of development and outcome of AKI in a cohort of Cirrhotics.(1 Years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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