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临床试验/NCT03675633
NCT03675633Unknown不适用

Fractional Excretion of Urea: an Excellent Simple Tool for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis

Assiut University0 个研究点目标入组 100 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
comparison of FEUrea in different types of AKI in liver cirrhosis

研究概览

简要总结

The aim of this study is to evaluate the diagnostic performance of FEUrea for the differential diagnosis of AKI in patients with cirrhosis and ascites Specifically, the ability of FEUrea to distinguish between ATN versus Pre renal azotemia and HRS.

详细描述

AKI according to KDIGO guidelines is defined as the followings:

  • An increase in serum creatinine by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 h
  • An increase in serum creatinine to ≥1.5 times baseline within the previous 7 days
  • Urine volume ≤0.5 ml/kg/h for 6 h Serum creatinine overestimates renal function in cirrhotic patients due to a number of factors: Creatinine production in patients with cirrhosis is reduced due to muscle wasting, there is an increased secretion of creatinine in the renal tubules, sCr may be diluted due to an increased volume of distribution, and finally, high bilirubin levels may interfere with the assays to measure its level. Recently, the International Club of Ascites (ICA) has adopted the concept of AKI which was developed originally to be used in general critically-ill patients. AKI is defined as the increase of at least 0.3 mg/dL (26 μmol/L) and/or ≥ 50% from baseline, within 48 hours Since urea absorption is largely modulated in the proximal tubules, it is not affected by diuretics acting more distally. The investigators therefore hypothesized that the fractional excretion of urea (FEUrea) could serve as a clinical aid in making an early distinction between ATN versus Pre renal azotemia and HRS type 1 in patients with cirrhosis and ascites presenting with AKI Fractional excretion of urea (FEUrea) ([urine urea nitrogen/ blood urea nitrogen)/(urine creatinine/plasma creatinine)] X 100) < 35% is specific for prerenal azotemia, and > 50% is specific for ATN

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

入选标准

  • Liver cirrhosis of any etiology diagnosed by clinical parameters involving laboratory tests, endoscopic or radiologic evidence of cirrhosis,
  • History of decompensation (hepatic encephalopathy, ascites, variceal bleeding, jaundice)
  • Age greater than 18 years
  • Presence of moderate or severe ascites

排除标准

  • Patients excluded from analysis were those who did not meet inclusion criteria as well as the following
  • Prior liver or kidney transplant,
  • Advanced chronic kidney disease G4(GFR category grade 4) according to KDIGO guidelines.
  • Patients on acute or chronic renal replacement therapy,
  • Ambiguous diagnosis of AKI and phenotype of AKI,
  • Patients with hepatocellular carcinoma.

结局指标

主要结局

comparison of FEUrea in different types of AKI in liver cirrhosis

时间窗: baseline

measurement of FEUrea in different types of AKI in decompansated liver cirrhosis to identify its cause

次要结局

未报告次要终点

研究者

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

Nermeen mahmoud mobarez

Doctor

Assiut University

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