Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05013502
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05013502
Study Brief:
Protocol Section:
NCT05013502