Clinical Trials Directory

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UnknownNCT03675633

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers

Summary

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.

Detailed description

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFEUreaFEUrea in decompansated liver cirrhosis

Timeline

Start date
2021-05-01
Primary completion
2021-12-31
Completion
2022-01-31
First posted
2018-09-18
Last updated
2021-02-24

Source: ClinicalTrials.gov record NCT03675633. Inclusion in this directory is not an endorsement.