Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis

Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis

This clinical trial compares a combination of two drugs that constrict blood vessels (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have cirrhosis and ascites.

This prospective, placebo-controlled, randomized, clinical trial compares the effect of a combination of vasoconstrictors (octreotide plus midodrine) to albumin on the time to recurrence of ascites in patients with refractory ascites treated with large volume paracentesis. The treatment allocation ratio for the two treatment arms is 1:1 using a stratified random permuted block design. Subjects are patients 18-80 years old with cirrhosis and ascites who are stratified according to the presence or absence of renal dysfunction at the time of randomization. Measurements include blood pressure, weight, girth, abdominal ultrasound, forearm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated during a 6 month period.

Inclusion Criteria:

• Cirrhosis of any etiology
• Age 18-80 years
• Moderate to severe ascites

Exclusion Criteria:

• No or small ascites
• Severe hepatic hydrothorax
• Recent GI (gastrointestinal) hemorrhage
• Active bacterial infection
• Cardiac failure
• Organic renal disease
• Hepatocellular carcinoma
• Severe comorbidity (advanced neoplasia)
• Serum creatinine > 3 mg/dl
• Pregnancy