Randomized Trial of Dapagliflozin Plus Standard Care Versus Standard Care Alone in Adults with Cirrhosis and Ascites to Improve Clinical Outcomes

What this Trial Is About

Researchers are evaluating the potential benefits of adding dapagliflozin, a sodium glucose cotransporter type 2 inhibitor originally used for diabetes, to the standard care regimen for adults with liver cirrhosis and ascites. The study aims to see if dapagliflozin can reduce the need for large volume paracentesis, decrease ICU admissions, improve quality of life, save healthcare costs, and lower mortality rates in these patients. Participants will be randomly assigned to one of two groups. Group A will receive standard care, which includes dietary sodium restriction, treatment with diuretics a combination of loop diuretics such as furosemide or torsemide and a distal-acting diuretic spironolactone, and large volume paracentesis as needed. Group B will receive dapagliflozin in addition to the standard care, with dosing based on their Child Pugh score 10 mgday for scores A and B, and 5 mgday for score C. Patients will be advised to stay hydrated and avoid alcohol throughout the treatment. During the study, participants will be monitored for adherence, body weight, symptoms of urinary tract infection, and sodium levels at 1 and 2 weeks after starting therapy and at the end of follow-up. Quality of life will be assessed at baseline and at the end using a questionnaire specific for chronic liver disease. The main outcome measured is the number of times paracentesis is needed over three months, along with monitoring the incidence of cirrhosis complications. The study runs from July 2026 to September 2027.

"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"