NCT00108355

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

Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ascites
• Cirrhosis

Interventions

Type	Name	Description
DRUG	Albumin	Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed
DRUG	Intravenous Saline Infusion (Albumin placebo)	Intravenous saline Infusion (Albumin placebo)
DRUG	Midodrine	Midodrine oral tablet at 10 mg three times a day.
DRUG	Oral tablet (Midodrine placebo)	Oral tablet (Midodrine placebo) three times a day
DRUG	Octreotide LAR	Octreotide LAR 20 mg intramuscular injection every 30 days
DRUG	Saline injection (Octreotide LAR placebo)	Saline intramuscular injection 5 cc every 30 days.
PROCEDURE	Large Volume Paracentesis	Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.

Timeline

• Start date: 2003-12-01
• Primary completion: 2010-08-01
• Completion: 2012-08-01
• First posted: 2005-04-15
• Last updated: 2014-03-06
• Results posted: 2014-03-06

Locations

1 site across 1 country: United States