Status:
COMPLETED
Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
About 30% of cirrhotic patients will develop ascites. Sodium restriction and diuretics are the first step treatment. Total paracentesis is used in patients with cirrhosis and tense ascites. Paracentes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00986817
Start Date
November 1 2009
End Date
April 1 2015
Last Update
June 15 2015
Active Locations (1)
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1
CARBONELL Nicolas
Paris, Paris, France, 75012