Status:
RECRUITING
SGLT-2 Inhibitors in the Treatment of Ascites
Lead Sponsor:
University of Palermo
Collaborating Sponsors:
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Conditions:
Ascites Hepatic
Cirrhosis, Liver
Eligibility:
All Genders
18-80 years
Brief Summary
The goal of this observational study is to test the efficacy of glyphozines (SGLT-2 inhibitors) in the control of ascites in patients with liver cirrhosis in class A6-B9, according to the Child-Pugh c...
Detailed Description
Background The occurrence of ascites and saline retention is the most common complication in patients affected by liver cirrhosis and it is associated with poor prognosis. It is well-known that in li...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years
- Patients diagnosed with Child-Turcotte-Pugh A6-B class Hepatic Cirrhosis (moderately impaired liver function)
- Patients diagnosed with Hepatic Cirrhosis of viral etiology (if previous hepatitis C virus (HCV) infection they must be in Sustained Virological Response (SVR); if previous hepatitis B virus (HBV) infection they must have undetectable viral genome)
- Patients diagnosed with hepatic cirrhosis of metabolic etiology
- Patients diagnosed with liver cirrhosis of alcoholic etiology (non active potus)
- Patients with grade 1 ascites: ascites detectable only ultrasound that can be fully mobilized or controlled with diuretic therapy associated with or without moderate dietary sodium restriction
- Grade 2 ascites: ascites that leads to a moderate abdominal distension and that recurs on at least 3 occasions within a 12-month period despite sodium restriction and adequate diuretic therapy (23)
- Patients diagnosed with type II diabetes mellitus defined according to 2022 American Diabetes Association (ADA) guidelines.
Exclusion
- Inability to obtain informed consent
- Ascites of non-cirrhotic origin
- Patients diagnosed with heart failure Heart (NYHA) class =\> 2
- Patients diagnosed with acute renal failure
- Patients diagnosed with chronic renal failure and glomerular filtration rate (eGFR) below 25ml/min
- Patients with hepatocellular carcinoma (diagnosed according to the Barcelona criteria) or other active tumors (25)
- Grade 3 ascites: ascites that causes marked distention of the abdomen and that cannot be mobilized or whose early recurrence (i.e. after large volume paracentesis) cannot be satisfactorily prevented by medical therapy
- Patients diagnosed with acute Spontaneous Bacterial Peritonitis (26)
- Patients diagnosed with severe hepatic encephalopathy
- Patients diagnosed with autoimmune diseases on active steroid treatment
- Patients diagnosed with liver cirrhosis due to storage diseases
- Patients diagnosed with cirrhosis of the liver due to enzyme deficiency
- Patients diagnosed with complete portal thrombosis
- Patients with active sepsis
- Pregnant or breastfeeding women
- Patients who use drugs
- Patients with active alcohol consumption
Key Trial Info
Start Date :
July 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05999773
Start Date
July 15 2023
End Date
December 31 2026
Last Update
December 6 2024
Active Locations (2)
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1
Internal Medicine Unit, V. Cervello Hospital
Palermo, Italy, Italy, 90100
2
Department of Internal Medicine, University Hospital of Palermo
Palermo, Palermo, Italy, 90127