Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FEUrea in decompensated liver cirrhosis

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

FEUrea

Intervention Type DIAGNOSTIC_TEST

FEUrea in decompansated liver cirrhosis

Interventions

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FEUrea

FEUrea in decompansated liver cirrhosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No