Midodrine in patients with cirrhosis and refractory or recurrent ascites: a randomized pilot study.

BACKGROUND & AIMS Splanchnic arterial vasodilatation plays an important role in cirrhotic ascites. The aim of this study was to evaluate the effects of long term administration of midodrine on systemic hemodynamics, renal function, and control of ascites in patients with cirrhosis and refractory or recurrent ascites. METHODS Forty cirrhotic patients with refractory or recurrent ascites were prospectively studied after long term administration of midodrine plus standard medical therapy (n=20) or standard medical therapy alone (n=20) in a randomized controlled trial at a tertiary centre. RESULTS A significant increase in urinary volume, urinary sodium excretion, mean arterial pressure, and decrease in plasma renin activity (p<0.05) was noted after 1 month of midodrine administration. There was also a significant decrease in cardiac output and an increase in systemic vascular resistance after midodrine therapy at 3 months (p<0.05). There was no change in glomerular filtration rate and model for end-stage liver disease (MELD) score. Midodrine plus standard medical therapy was significantly superior to standard medical therapy alone in the control of ascites (p=0.013) at 3 months. The mortality rate in the standard medical therapy group was significantly higher than the midodrine group (p<0.046). There was no significant difference in the frequency of various complications at the end of follow-up. CONCLUSIONS The results of this randomized pilot study suggest that midodrine plus standard medical therapy improves the systemic hemodynamics without any renal or hepatic dysfunction in these patients and is superior to standard medical therapy alone for the control of ascites.