Conditions: Ascites Cirrhosis
Keywords: albumin ascites paracentesis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: After LVP, patients in this group received:

Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo) arm 2: After LVP, patients in this group received:

Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose

Interventions: intervention 1: Albumin intervention 2: Intravenous Saline Infusion (Albumin placebo) intervention 3: Midodrine intervention 4: Oral tablet (Midodrine placebo) intervention 5: Octreotide LAR intervention 6: Saline injection (Octreotide LAR placebo) intervention 7: Large Volume Paracentesis
Intervention descriptions: intervention 1: Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed intervention 2: Intravenous saline Infusion (Albumin placebo) intervention 3: Midodrine oral tablet at 10 mg three times a day. intervention 4: Oral tablet (Midodrine placebo) three times a day intervention 5: Octreotide LAR 20 mg intramuscular injection every 30 days intervention 6: Saline intramuscular injection 5 cc every 30 days. intervention 7: Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.

Protocol document: