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

NCT00108355 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-03-06

Study results available
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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.

Conditions

  • Ascites
  • Cirrhosis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Guadalupe Garcia-Tsao, MD · VA Connecticut Health Care System (West Haven)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2010-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00108355 on ClinicalTrials.gov