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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Lypressin; Terlipressin

Criteria

Inclusion Criteria:

• Patient aged 18 years old and more with cirrhosis and refractory ascites define by the international ascites club.

• Vital status non engaged in the 2 months

Exclusion Criteria:

• cardiovascular disease : previous or actual angina pectoralis, myocardial infarction, heart failure, rhythm or conduction disorders, repolarisation abnormality on ECG

• respiratory disease: previous or actual chronic pulmonary insufficiency, asthma

• uncontrolled hypertension

• acute portal vein thrombosis (less then 3 months) or currently treated.

• chronic renal insufficiency (creatin > 15 mg/L)

• severe hepatic encephalopathy

• Alcoholic hepatitis or gastrointestinal bleeding in the last 3 months

• hepatocellular carcinoma

• severe illness with life threatening

• pregnant or breastfeeding women