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Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin

NCT00986817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2015-06-15

No results posted yet for this study

Summary

Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first step treatment. Refractory ascites (not responding to first step treatment) is treated with repeated large volume paracentesis followed by intra venous albumin expansion. In pilot studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites production. Therefore the investigators will study the effect of combined therapy with albumin and terlipressin on recidivation ascites.

Conditions

  • Cirrhosis

Interventions

DRUG

Terlipressin

Albumin perfusions at the dose 8 g/l of removed ascites and Terlipressin (1mg), administrated before and at the end of the paracentesis.

DRUG

Placebo

albumin perfusion at the dose 8 g/l of removed ascites and placebo, administrated before and at the end of the paracentesis.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nicolas Carbonell, MD · Hôpital Saint Antoine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2015-03-31
Completion
2015-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00986817 on ClinicalTrials.gov