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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Diagnostic test: FEUrea

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Nermeen Mobarez, specialist; Phone Number: 00201098800485; Email: nermeenmobarez@gmail.com
• Study Contact Backup: Name: Essam Abdel Aziz, lecturer; Phone Number: 00201009699081; Email: essam.nephro@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

compensated and decompensated rrhotic patients

Description

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: FEUrea; FEUrea in decompansated liver cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of FEUrea in different types of AKI in liver cirrhosis	measurement of FEUrea in different types of AKI in decompansated liver cirrhosis to identify its cause	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Piano S, Brocca A, Angeli P. Renal Function in Cirrhosis: A Critical Review of Available Tools. Semin Liver Dis. 2018 Aug;38(3):230-241. doi: 10.1055/s-0038-1661372. Epub 2018 Jul 24.
• Durand F, Olson JC, Nadim MK. Renal dysfunction and cirrhosis. Curr Opin Crit Care. 2017 Dec;23(6):457-462. doi: 10.1097/MCC.0000000000000457.
• Bucsics T, Krones E. Renal dysfunction in cirrhosis: acute kidney injury and the hepatorenal syndrome. Gastroenterol Rep (Oxf). 2017 May;5(2):127-137. doi: 10.1093/gastro/gox009. Epub 2017 Apr 24.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: September 15, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Kidney Diseases; Urologic Diseases; Liver Diseases; Renal Insufficiency; Fibrosis; Liver Cirrhosis; Acute Kidney Injury
• Other Study ID Numbers: FEUrea in liver cirrhosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No