Empagliflozin in Diuretic Refractory Ascites (NCT05013502) | Clinical Trial Compass
CompletedPhase 1
Empagliflozin in Diuretic Refractory Ascites
United States14 participantsStarted 2021-11-15
Plain-language summary
Ascites is the most frequent complication of liver cirrhosis and results in increased morbidity and mortality but current medical management options are limited. Here, the investigators will conduct an interventional single-arm pilot clinical trial toevaluate the feasibility of empagliflozin in managing diuretic-resistant ascites in patients with decompensated cirrhosis. This single site, open label pilot study will enroll participants with decompensated cirrhosis at a single site. Participants will receive empagliflozin 10mg oral tablets once daily for 12 weeks with monitoring for safety and adverse events.
Who can participate
Age range
18 Years – 75 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:
* Decompensated liver cirrhosis with ascites
* Diuretic-resistant ascites defined as one of the following: a) An inability to mobilize ascites despite adherence to dietary sodium restriction (2000 mg per day) and administration of maximum tolerable doses of oral diuretics; b) Rapid reaccumulation of fluid after therapeutic paracentesis despite adherence to a sodium-restricted diet. c) Development of diuretic-related complications such as progressive azotemia, hepatic encephalopathy, or progressive electrolyte imbalances
* Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
* Hypersensitivity to any SGLT2 inhibitor
* Pregnant or breastfeeding women
* eGFR below 45mL/min/1.73m2 or decrease in eGFR by \>30% between screening
* Recurrent urinary tract infections or recurrent genitourinary fungal infections, defined as \> 2 infections in six months or \>3 infections in one year
* Hypotension requiring oral vasopressor therapy
* Patients with particular risk for ketoacidosis including active moderate or severe alcohol use disorder, pancreatitis, pancreatic insulin deficiency from any cause, or episode of ketoacidosis in the past
* History of skin or soft tissue infection requiring IV antibiotics including Fornier's gangrene or prior limb amputation
* Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
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
Participant retention rate as a measure of study feasibility