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


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Cirrhosis

Cirrhosis (Primary Biliary); Cirrhosis of the Liver; Liver Cirrhosis


Clinical Trial: Vasoconstrictors as Alternatives to Albumin after LVP (Large-Volume Paracentesis) in Cirrhosis

This study is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

This clinical trial compares a combination of two drugs that constrict blood vessels (Sandostatin LAR and Midodrine) to albumin after large volume paracentesis. Subjects have cirrhosis and ascites.

Condition Treatment or Intervention Phase
Cirrhosis
Ascites
 Drug: octreotide plus midodrine
 Drug: albumin
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Vasoconstrictors as Alternatives to Albumin after LVP in Cirrhosis

Further Study Details: 

Study start: December 2003;  Expected completion: December 2006

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, forerm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated during a 6 month period.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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 baterial infection
  • Cardiac failure
  • Organic renal disease
  • Hepatocellular carcinoma
  • Severe comorbidity (advanced neoplasia)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00108355


Connecticut
      VA Connecticut Healthcare System, West Haven,  Connecticut,  06516,  United States; Recruiting
Fred Wright, M.D.  203-937-3830    fred.wright@med.va.gov 
Guadalupe Garcia-Tsao, M.D.,  Principal Investigator

More Information

Study ID Numbers:  CL-016-03F
Record last reviewed:  April 2005
Last Updated:  April 14, 2005
Record first received:  April 14, 2005
ClinicalTrials.gov Identifier:  NCT00108355
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005


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Page Updated: May 11, 2006
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