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Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Liver 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: NCT03675633
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nermeen mahmoud mobarez, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Liver Cirrhosis 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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fractional Excretion of Urea: an Excellent Simple Tool for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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




Primary Outcome Measures :
  1. comparison of FEUrea in different types of AKI in liver cirrhosis [ Time Frame: baseline ]
    measurement of FEUrea in different types of AKI in decompansated liver cirrhosis to identify its cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
compensated and decompensated rrhotic patients
Criteria

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.

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): NCT03675633


Contacts
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Contact: Nermeen Mobarez, specialist 00201098800485 nermeenmobarez@gmail.com
Contact: Essam Abdel Aziz, lecturer 00201009699081 essam.nephro@gmail.com

Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: Nermeen mahmoud mobarez, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03675633    
Other Study ID Numbers: FEUrea in liver cirrhosis
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Acute Kidney Injury
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases