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临床试验/NCT03530761
NCT03530761Unknown不适用

Kidney Biomarkers for the Prediction of Response to Terlipressin and Survival in Cirrhotic Patients With Acute Kidney Injury: Multicenter, Prospective Cohort Study

Soonchunhyang University Hospital1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
245
试验地点
1
主要终点
Overall survival

研究概览

简要总结

The aim of this study is to investigate i) whether two biomarkers (urine NAG, urinary cystatin C) could be predictive factor in patient with liver cirrhosis, , and ii) whether these biomarkers can predict response of terlipressin.

详细描述

Acute kidney injury (AKI) in patients with liver cirrhosis is sometimes accompanied by tubular injury which can lead to poor outcome. Current AKI criteria using serum creatinine (Cr) has some limitations to predict reversibility of renal function and discriminate renal parenchymal injury in cirrhotic patients. The aim of this study is to evaluate whether urine biomarkers [cystatin C, N-acetyl-β-D-Glucosaminidase (NAG)] can predict survival and response to terlipressin in cirrhotic patients with AKI.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
  • Patients who voluntarily agreed to the study

排除标准

  • Patients with active bleeding (eg, varix bleeding) within 7 days
  • Patients with hepatocellular carcinoma
  • Patients with hypersensitivity to terlipressin
  • Patients with anuria
  • Pregnant and lactating patients
  • Patients who did not agree with the study

结局指标

主要结局

Overall survival

时间窗: up to 3 years

From date of sample collection until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

次要结局

  • Transplantation free survival(up to 3 years)
  • Regression of acute kidney injury(up to 1 month)
  • Recurrence of acute kidney injury(up to 1 year)
  • Progression to chronic kidney disease(1 year)
  • Response rate to terlipressin(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Gyune Kim

Associate proffesor

Soonchunhyang University Hospital

研究点 (1)

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