Acute Kidney InjuryNCT04986137
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
An observational study of Acute Kidney Injury, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Sep 2021to Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospitals
Aswān
mahmoud.khalaf@med.aswu.edu.eg
About this study
Official title: Diagnostic Performance of Fractional Excretion of Urea in Acute Kidney Injury in Patients With Liver Cirrhosis
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).
Read the 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.
- Conditions
- Acute Kidney Injury
- Keywords
- ascites, hepatorenal syndrome, acute tubular necrosis, pre-renal azotemia, cirrhosis
- Medical subject headings
- Acute Kidney Injury, Ascites, Hepatorenal Syndrome, Kidney Cortex Necrosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fractional excretion of urea percentage in urine
By equation : [(urine Na ÷ serum Na) ÷ (urine creatinine ÷ serum creatinine)] x 100%
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start4 Sep 2021
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khalaf Mahmoud, Sohag University
- Investigators
- Eman A Sabet, Professor, Principal investigator, Suhag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986137
- Sponsor's protocol ID
- Soh-Med-21-07-25
- Status last verified
- Oct 2022
- First submitted
- 16 Jul 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Fractional Excretion of Urea in Acute Kidney Injury in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04986137
- Acronym / sponsor ID
- Soh-Med-21-07-25
- Conditions
- Acute Kidney Injury
- Keywords
- ascites, hepatorenal syndrome, acute tubular necrosis, pre-renal azotemia, cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 2 Aug 2021 (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 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).
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Eman A Sabet, Professor principal investigator
Suhag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Sohag University at 1 site in Egypt.
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 4 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Eman A Sabet, Professor (00200102907077, eman_thabet@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fractional excretion of urea percentage in urine (time frame: "through study completion, an average of 1 year".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2022.