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Completed

NCT Number: NCT00108355

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

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Key information

Conditions

Ascites Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALBUMIN

Drug

Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed

Intravenous Saline Infusion (Albumin placebo)

Drug

Intravenous saline Infusion (Albumin placebo)

Midodrine

Drug

Midodrine oral tablet at 10 mg three times a day.

Oral tablet (Midodrine placebo)

Drug

Oral tablet (Midodrine placebo) three times a day

Octreotide LAR

Drug

Octreotide LAR 20 mg intramuscular injection every 30 days

Saline injection (Octreotide LAR placebo)

Drug

Saline intramuscular injection 5 cc every 30 days.

Large Volume Paracentesis

Procedure

Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.

Other names: LVP

Primary outcomes

  1. Time to Recurrence of Ascites.

    Time frame: Variable depending on the patient, average 10 days

    Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis

Important dates

Study start
2003
Primary completion
2010
Study completion
2012
First posted
Apr 15, 2005
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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