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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04986137
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Mahmoud Khalaf Mahmoud, Sohag University

Study Description
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Brief 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).

Condition or disease
Acute Kidney Injury

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Diagnostic Performance of Fractional Excretion of Urea in Acute Kidney Injury in Patients With Liver Cirrhosis
Actual Study Start Date : September 4, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in fractional excretion of urea percentage in urine [ Time Frame: "through study completion, an average of 1 year". ]
    By equation : [(urine Na ÷ serum Na) ÷ (urine creatinine ÷ serum creatinine)] x 100%


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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:

  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04986137


Contacts
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Contact: Eman A Sabet, Professor 00200102907077 eman_thabet@med.sohag.edu.eg
Contact: Mahmoud Kh Mahmoud, Doctor +201092292409 mahmoud.khalaf@med.aswu.edu.eg

Locations
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Egypt
Aswan University Hospitals Recruiting
Aswan, Egypt
Contact: mahmoud.khalaf@med.aswu.edu.eg         
Sponsors and Collaborators
Sohag University
Investigators
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Principal Investigator: Eman A Sabet, Professor Suhag University
More Information
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Responsible Party: Mahmoud Khalaf Mahmoud, Assistant lecturer of Internal Medicine. Faculty of Medicine, Aswan University, Sohag University
ClinicalTrials.gov Identifier: NCT04986137    
Other Study ID Numbers: Soh-Med-21-07-25
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Khalaf Mahmoud, Sohag University:
ascites
hepatorenal syndrome
acute tubular necrosis
pre-renal azotemia
cirrhosis
Additional relevant MeSH terms:
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Acute Kidney Injury
Fibrosis
Wounds and Injuries
Pathologic Processes
Renal Insufficiency
Kidney Diseases
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases