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Status unknownNCT04986137Updated Oct 28, 2022

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

An observational study in Acute Kidney Injury, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-28.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to evaluate:

  • The diagnostic performance of Fractional Excretion of Urea (FEUrea) for the differential diagnosis of acute kidney injury in patients with cirrhosis and ascites presenting to a tertiary care hospital.
  • The ability of Fractional Excretion of Urea to distinguish between

    1. structural group of acute kidney injury (acute tubular necrosis) versus functional group of acute kidney injury (prerenal azotemia and hepatorenal syndrome), and
    2. types of functional group (prerenal azotemia versus hepatorenal syndrome type 1).
Read the detailed description

Acute kidney injury (AKI) is a common complication of end-stage liver disease and is one of the criteria that define acute-on-chronic liver failure.

There are two types of AKI in cirrhosis: functional and structural. The functional group is divided into the volume responsive prerenal azotemia (PRA) that results from decreases in intravascular volume (e.g., aggressive diuretic treatment, diarrhea) and volume-unresponsive state or called hepatorenal syndrome (HRS). AKI that is unresponsive to albumin infusion and withdrawal of diuretics in the absence of identifiable causes. The structural group includes acute tubular necrosis (ATN) that results from intrinsic damage and other renal parenchymal disorders.

Urea is filtered in the glomerulus and then largely reabsorbed in the proximal tubule and also in the distal tubule. The reabsorption of urea is increased by vasopressin and the renin-angiotensin-aldosterone system. The fractional excretion of urea under conditions of decreased renal perfusion and increased vasopressin and renin-angiotensin-aldosterone system (RAAS), such as that seen in cirrhosis with PRA or HRS type 1, should therefore decrease. Conversely, renal tubular injury should impair reabsorption and increase its fractional excretion. Since urea absorption is largely modulated in the proximal tubules, it is not affected by diuretics acting more distally. Recently it is therefore hypothesized that the fractional excretion of urea (FEUrea) could serve as a clinical aid in making an early distinction between ATN versus PRA and HRS type 1 in patients with cirrhosis and ascites presenting with AKI. The current study was designed to test this hypothesis.

02

Conditions studied

  • Acute Kidney Injury

Keywords

  • ascites
  • hepatorenal syndrome
  • acute tubular necrosis
  • pre-renal azotemia
  • cirrhosis
03

In context

Acute Kidney Injury

1,596 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 100 is below the median of 151 across 774 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Potential patients will be identified by screening all cirrhotic patients who will be admitted with acute kidney injury to a specialized hepatology inpatient unit or who will attend for follow up at outpatient clinics

Inclusion criteria

  • Age greater than 18 years.
  • Decompensated liver cirrhosis (Child-Pugh classification B or more) 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), and liver biopsy if available.
  • Use of either loop diuretics and/or distal diuretics (ex; spironolactone and eplerenone) until the time of admission.
  • Availability of a baseline serum creatinine as defined by the International Club Ascites.

Exclusion criteria

Exclusion Criteria:

  • Prior liver or kidney transplant
  • Advanced chronic kidney disease defined as serum creatinine greater than 4 mg/dL
  • Patients on acute or chronic renal replacement therapy
  • Patients with hepatocellular carcinoma.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Acute kidney injury due to acute tubular necrosis

  • Group 2

    Acute kidney injury due to prerenal azotemia

  • Group 3

    Acute kidney injury due to hepatorenal syndrome type 1

06

What researchers measure

Primary outcomes

  1. Change in fractional excretion of urea percentage in urine

    By equation : \[(urine Na ÷ serum Na) ÷ (urine creatinine ÷ serum creatinine)\] x 100%

    Time frame: "through study completion, an average of 1 year".

07

Study locations

1 of 1 sites recruiting
  • Aswan University Hospitals
    Aswan, Egypt
    • mahmoud.khalaf@med.aswu.edu.eg · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04986137
Lead sponsor
Sohag University
Responsible party
Mahmoud Khalaf Mahmoud (Assistant lecturer of Internal Medicine. Faculty of Medicine, Aswan University, Sohag University) — Principal investigator
First posted
Aug 2, 2021
Start date
Sep 4, 2021
Primary completion
Nov 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Oct 28, 2022

Study contacts

Eman A Sabet, Professor
Contact
eman_thabet@med.sohag.edu.eg
00200102907077
Mahmoud Kh Mahmoud, Doctor
Contact
mahmoud.khalaf@med.aswu.edu.eg
+201092292409
Eman A Sabet, Professor
principal investigator · Suhag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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