cirrhosis of the liver, ascites
Conditions
Interventions
Patients will be randomly assigned to receive either terlipressin or albumin, the standard treatment, iv when they receive a therapeutic paracentesis.
The terlipressin group will receive an iv-bolus o
Sponsors
Foundation for Liver Research (SLO)
Erasmus MC
c/o department of hepatology and gastroenterology,room Ca 326
Dr. Molewaterplein 40
3015 GD Rotterdam
tel (010) 463 5942
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cirrhosis with tense ascites requiring therapeutic paracentesis; 2. Age 18-70; 3. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Hypertension treated with medication; 2. History of cardiac or coronary disease; 3. Circulatory unstable; 4. Until 5 days prior to paracentesis: a. Infusion of a plasma expander; b. Gastro-intestinal haemorrhage; c. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in EABV. This is an increase in plasma renin concentration (PRC) of more than 50% of baseline values 6 days after paracentesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Circulatory parameters; 2. Renal function; 3. Bodyweight (recurrence of ascites); 4. Adverse events; 5. Costs. | — |
Contacts
Public ContactJ.J. Kuiper
Erasmus Medical Center, Department of Hepatology and Gastroenterology, room Ca 326a, Dr. Molewaterplein 40
Outcome results
None listed