About this trial
This study aims to evaluate beneficial effects of using dapagliflozin in cirrhotic chronic liver disease patients. We hypnotized that the use of dapagliflozin will be associated with fewer need for large volume paracentesis hence better control of ascites, fewer need for ICU admissions, improvement of patient quality of life, better healthcare cost saving and reduced mortality rate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study.
Disqualifiers
Child Pugh score ≥ 12 or MELD score > 25.
Previous history of hypoglycemia or has a previous history of DKA.
Blood pressure less than 90/60 or need dose of midodrine >15 mg/day.
Previous history of recurrent urinary tract infections (more than 2 infections in the last 6 months) or anatomic urologic defects that predispose to urinary tract infection.
Trial design
Parallel
Treatments tested in this trial
Dapagliflozin
DrugDapagliflozin is sodium glucose cotransporter type 2 inhibitors (SGLT-2i) primary an antidiabetic drug but now used in chronic heart failure and chronic kidney disease.
Treatment groups
Trial outcomes
Primary outcomes
Number of times patient need Paracentesis to control Ascites
Decrease need for large volume paracentesis in the intervention group than in the control group which indicate better control of Ascites within 3 months from the start of intervention.
Secondary outcomes
incidence of Cirrhosis sequelae
• Reduced incidence of Cirrhosis sequelae (hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, variceal bleeding) in the intervention group as compared to control group.
Other outcomes
quality of life using SF-36 questionnaire
• Improvement of patient quality of life in the intervention group as compared to control group.
Sponsors and contacts
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