Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis (NCT04986137) | Clinical Trial Compass
UnknownNot Applicable
Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Egypt100 participantsStarted 2021-09-04
Plain-language 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. structural group of acute kidney injury (acute tubular necrosis) versus functional group of acute kidney injury (prerenal azotemia and hepatorenal syndrome), and
2. types of functional group (prerenal azotemia versus hepatorenal syndrome type 1).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in fractional excretion of urea percentage in urine
Timeframe: "through study completion, an average of 1 year".