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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108355
First received: April 14, 2005
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Ascites
Cirrhosis
Drug: Albumin
Drug: Intravenous Saline Infusion (Albumin placebo)
Drug: Midodrine
Drug: Oral tablet (Midodrine placebo)
Drug: Octreotide LAR
Drug: Saline injection (Octreotide LAR placebo)
Procedure: Large Volume Paracentesis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Time to Recurrence of Ascites. [ Time Frame: Variable depending on the patient, average 10 days ] [ Designated as safety issue: No ]
    Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)


Secondary Outcome Measures:
  • Development of Post-paracentesis Circulatory Dysfunction (PCD) [ Time Frame: 6 days after paracentesis ] [ Designated as safety issue: No ]
    Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day


Enrollment: 29
Study Start Date: December 2003
Study Completion Date: August 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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
Procedure: Large Volume Paracentesis
Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.
Other Name: LVP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108355

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Investigators
Principal Investigator: Guadalupe Garcia-Tsao, MD VA Connecticut Health Care System (West Haven)
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108355     History of Changes
Obsolete Identifiers: NCT00530959
Other Study ID Numbers: CLIN-016-03F
Study First Received: April 14, 2005
Results First Received: December 11, 2013
Last Updated: February 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
albumin
ascites
paracentesis

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Digestive System Diseases
Liver Diseases
Pathologic Processes
Midodrine
Octreotide
Vasoconstrictor Agents
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Cardiovascular Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014