Randomized control trial on the effects of rifaximin and midodrine combined with standard diuretic therapy versus midodrine with standard diuretic therapy in chronic liver disease patients with refractory ascites

Refractory ascites is a serious complication of advanced liver cirrhosis in which ascites does not respond to sodium restriction and standard diuretic therapy or recurs rapidly after therapeutic paracentesis. It is associated with poor prognosis and high mortality. A proportion of patients with cirrhosis and ascites eventually develop refractory ascites, and mortality in this group remains high within one to two years.

Liver transplantation is the only definitive treatment for refractory ascites but is not feasible for many patients due to limited availability and medical or socioeconomic constraints. As a result most patients are managed with diuretics and repeated large volume paracentesis. Diuretic therapy in these patients often leads to complications such as hyponatremia acute kidney injury and hepatic encephalopathy. Recurrent paracentesis increases the risk of infections including spontaneous bacterial peritonitis.

Midodrine improves renal perfusion and renal function by increasing systemic vascular resistance. Rifaximin reduces oxidative stress and splanchnic vasodilation and may improve circulatory dysfunction in cirrhosis. Previous studies have suggested that adding midodrine and rifaximin to standard therapy can enhance diuresis improve renal and systemic hemodynamics and increase short term survival in patients with refractory ascites.

However there is limited data from India regarding the combined use of rifaximin and midodrine in refractory ascites. This study is designed to evaluate whether the addition of rifaximin and midodrine to standard therapy improves diuresis and survival outcomes in patients with refractory ascites.