NCT03675633Unknown不适用
Fractional Excretion of Urea: an Excellent Simple Tool for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis
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
- 否
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
Nermeen mahmoud mobarez
Doctor
Assiut University
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