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

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 4

Conditions: Cirrhosis; Ascites

Treatments: Drug: Oral tablet (Midodrine placebo); Drug: Octreotide LAR; Drug: Saline injection (Octreotide LAR placebo); Procedure: Large Volume Paracentesis; Drug: Albumin; Drug: Midodrine; Drug: Intravenous Saline Infusion (Albumin placebo)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00108355

CLIN-016-03F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Albumin (Control group)

Active Comparator group

Description:

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)

Treatment:

Drug: Oral tablet (Midodrine placebo)

Procedure: Large Volume Paracentesis

Drug: Albumin

Drug: Saline injection (Octreotide LAR placebo)

Vasoconstrictor (Study Group)

Experimental group

Description:

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

Treatment:

Drug: Octreotide LAR

Procedure: Large Volume Paracentesis

Drug: Midodrine

Drug: Intravenous Saline Infusion (Albumin placebo)