NCT03675633

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
2.6 years until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

September 15, 2018

Last Update Submit

February 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

FEUreaDIAGNOSTIC_TEST

FEUrea in decompansated liver cirrhosis

FEUrea in decompensated liver cirrhosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

compensated and decompensated rrhotic patients

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30041275BACKGROUND
  • 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.

    PMID: 29023314BACKGROUND
  • 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.

    PMID: 28533910BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nermeen Mobarez, specialist

CONTACT

Essam Abdel Aziz, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 15, 2018

First Posted

September 18, 2018

Study Start

May 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

February 24, 2021

Record last verified: 2021-02