Status:
COMPLETED
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Ascites
Cirrhosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- Cirrhosis of any etiology
- Age 18-80 years
- Moderate to severe ascites
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00108355
Start Date
December 1 2003
End Date
August 1 2012
Last Update
March 6 2014
Active Locations (1)
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1
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516