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.
|
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
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
Connecticut
VA Connecticut Healthcare System, West Haven, Connecticut, 06516, United States; Recruiting
Guadalupe Garcia-Tsao, M.D., Principal Investigator
More Information
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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