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

NCT04986137 | Unknown

• 1 other identifier: Soh-Med-21-07-25
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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
• structural group of acute kidney injury (acute tubular necrosis) versus functional group of acute kidney injury (prerenal azotemia and hepatorenal syndrome), and
• types of functional group (prerenal azotemia versus hepatorenal syndrome type 1).

Conditions

Acute Kidney Injury

Keywords

ascites; hepatorenal syndrome; acute tubular necrosis; pre-renal azotemia; cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change in fractional excretion of urea percentage in urine

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

  "through study completion, an average of 1 year".

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Aswan University Hospitals

Aswān, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Ascites; Hepatorenal Syndrome; Kidney Cortex Necrosis; Fibrosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Eman A Sabet, Professor

  Suhag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman A Sabet, Professor

CONTACT

00200102907077; eman_thabet@med.sohag.edu.eg

Mahmoud Kh Mahmoud, Doctor

CONTACT

+201092292409; mahmoud.khalaf@med.aswu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Internal Medicine. Faculty of Medicine, Aswan University

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 2, 2021
• Study Start: September 4, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)