Liver CirrhosisNCT03675633
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- FEUrea
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: compensated and decompensated rrhotic patients
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fractional Excretion of Urea: an Excellent Simple Tool for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis
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.
Read the 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
- Conditions
- Liver Cirrhosis
- Being tested
- FEUrea
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEUreaDiagnostic test
FEUrea in decompansated liver cirrhosis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: FEUrea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen mahmoud mobarez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675633
- Sponsor's protocol ID
- FEUrea in liver cirrhosis
- Status last verified
- Feb 2021
- First submitted
- 15 Sep 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30041275Durand F, Olson JC, Nadim MK. Renal dysfunction and cirrhosis. Curr Opin Crit Care. 2017 Dec;23(6):457-462. doi: 10.1097/MCC.0000000000000457.
PubMed 29023314Bucsics 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.
PubMed 28533910
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Excretion of Urea: an Excellent Simple Tool for the Differential Diagnosis of Acute Kidney Injury in Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03675633
- Acronym / sponsor ID
- FEUrea in liver cirrhosis
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEUrea in decompensated liver cirrhosis | – | Diagnostic Test: FEUreaFEUrea 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- compensated and decompensated rrhotic patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEUreaFEUrea in decompansated liver cirrhosis | Diagnostic test | FEUrea in decompensated liver cirrhosis |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 30041275Piano 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.
- Background: PubMed 29023314Durand F, Olson JC, Nadim MK. Renal dysfunction and cirrhosis. Curr Opin Crit Care. 2017 Dec;23(6):457-462. doi: 10.1097/MCC.0000000000000457.
- Background: PubMed 28533910Bucsics 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen Mobarez, specialist (00201098800485, nermeenmobarez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of FEUrea in different types of AKI in liver cirrhosis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03675633, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.