CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
Albumin +6 moredrug
Likely dose
Albumin 8 g per liter of ascitic fluid removed; Midodrine 10 mg orally three times daily; Octreotide LAR 20 mg intramuscular injection every 30 daysAI-extracted
Key inclusion· 3
  • ✓Cirrhosis of any etiology
  • ✓Age 18-80 years
  • ✓Moderate to severe ascites
Key exclusion· 9
  • ✕No or small ascites
  • ✕Severe hepatic hydrothorax
  • ✕Recent GI hemorrhage
  • ✕Active bacterial infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00108355
NCT00108355Phase 4Completed
CompareCT.gov

Vasoconstrictors as Alternatives to Albumin After Large Volume Paracentesis in Cirrhosis

US Department of Veterans Affairs·interventional·Posted Apr 15, 2005·Updated Mar 6, 2014

In Brief

A Phase 4 clinical trial evaluating Albumin, Intravenous Saline Infusion (Albumin placebo), and 5 other interventions for Ascites and Cirrhosis. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAscites, Cirrhosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2005
Enrollment StartDec 1, 2003
Primary CompletionAug 1, 2010
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 21.2 years ago

Interventions

Albumindrug

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

Intravenous Saline Infusion (Albumin placebo)drug

Intravenous saline Infusion (Albumin placebo)

Midodrinedrug

Midodrine oral tablet at 10 mg three times a day.

Oral tablet (Midodrine placebo)drug

Oral tablet (Midodrine placebo) three times a day

Octreotide LARdrug

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 Paracentesisprocedure

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