Terlipressin versus albumin in the prevention of paracentesis-associated adverse events in patients with cirrhosis and tense ascites

Completed

• Conditions: Cirrhosis of the liver/ascites; Digestive System; Fibrosis and cirrhosis of liver

• Registration Number: ISRCTN36383299
• Lead Sponsor: Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Cirrhosis with tense ascites requiring therapeutic paracentesis
2. Aged 18 - 70 years
3. Written informed consent

Exclusion Criteria

1. Hypertension treated with medication
2. History of cardiac or coronary disease
3. Circulatory unstable
4. Until 5 days prior to paracentesis:
4.1. Infusion of a plasma expander
4.2. Gastro-intestinal haemorrhage
4.3. Spontaneous bacterial peritonitis
5. Systemic administration of antibiotics within the past 14 days for a period of more than 24 hours, with the exception of quinolones
6. Hepatocellular carcinoma
7. Hepatic encephalopathy
8. Pregnancy or lack of adequate contraception in sexually active females
9. Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified