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

February 3, 2014 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Health Care System (West Haven)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Albumin (Control group)

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)
Drug: Albumin
Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed
Drug: Oral tablet (Midodrine placebo)
Oral tablet (Midodrine placebo) three times a day
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.
Other Names:
  • LVP
Experimental: Vasoconstrictor (Study Group)

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
Procedure: Large Volume Paracentesis
Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.
Other Names:
  • LVP
Drug: Intravenous Saline Infusion (Albumin placebo)
Intravenous saline Infusion (Albumin placebo)
Drug: Midodrine
Midodrine oral tablet at 10 mg three times a day.
Drug: Octreotide LAR
Octreotide LAR 20 mg intramuscular injection every 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recurrence of Ascites.
Time Frame: Variable depending on the patient, average 10 days
Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)
Variable depending on the patient, average 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Post-paracentesis Circulatory Dysfunction (PCD)
Time Frame: 6 days after paracentesis
Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day
6 days after paracentesis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 14, 2005

First Submitted That Met QC Criteria

April 14, 2005

First Posted (Estimate)

April 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-016-03F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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