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临床试验/NCT05161910
NCT05161910已完成不适用

Urinary Biomarker Neutrophil Gelatinase Associated Lipocalcin (NGAL) in Early Prediction of AKI in Cirrhosis of Liver

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3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
120
试验地点
1
主要终点
To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group.

研究概览

简要总结

Kidney dysfunction is a complex and common event in patients with liver cirrhosis. Although novel treatments have shown some promising results , acute kidney injury remains a major complication of decompensated liver cirrhosis with high morbidity and mortality rates . AKI occurs in up to 19-20% of hospitalized patients with liver cirrhosis and among the most frequent causes are prerenal azotemia (PRA), hepatorenal syndrome and acute tubular necrosis , with prevalence rates estimated around 68%, 25%, and 33%, respectively.

The introduction and widespread use of diagnostic criteria of AKI in the area of cirrhosis has contributed to an increased awareness and earlier detection of AKI. However, some important problems remain. One of the main issues is the differential diagnosis of AKI, particularly between acute tubular necrosis (ATN) and hepatorenal syndrome (HRS-AKI). This is important because treatment is different; renal replacement therapy (RRT) is used for the former, and vasoconstrictors and albumin are used for the latter.

详细描述

Aim of the study:

To determine utility of NGAL in chronic liver disease patients with acute kidney injury.

Objective:

  1. To compare urine NGAL values in HRS and Non-HRS group.
  2. To determine optimal cutoff of urine NGAL for early determination of HRS.

Plan of investigation:

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

入选标准

  • Cirrhosis diagnosis by combination of clinical, laboratorial, endoscopic and imaging
  • Age over 18 years old
  • Acute kidney injury (defined by ICA-AKI criteria)
  • Agreement to participate in the study

排除标准

  • Shock/CCF
  • Age less than 18yrs •
  • Underwent renal replacement therapy within the last 6 week prior to evaluation
  • Prior kidney or liver transplantation
  • Confirmed pregnancy
  • Established CKD
  • Congestive cardiac failure
  • Patients who have taken diuretics in the last 48 hours

结局指标

主要结局

To compare urine Neutrophil Gelatinase Associated lipocalcin values in Hepato renal syndrome and Non-Hepato renal syndrome group.

时间窗: 12 months

Kidney biomarkers appear to be useful in differential diagnosis between acute tubular necrosis (ATN) and other types of acute kidney injury (AKI) in cirrhosis, particularly hepatorenal syndrome (HRS-AKI)

次要结局

  • . To determine optimal cutoff of urine NGAL for early determination of HRS.(12 months)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

Clinical Professor

Asian Institute of Gastroenterology, India

研究点 (1)

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