Terlipressin versus albumin in the prevention of paracentesis associated adverse events in patients with cirrhosis and tense ascites. A multicenter randomised controlled trial.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR463
• Date of registration: 24/10/2005
• Primary sponsor: Erasmus Medical Center, Department of Hepatology and Gastroenterology
• Public title: Terlipressin versus albumin in the prevention of paracentesis associated adverse events in patients with cirrhosis and tense ascites. A multicenter randomised controlled trial.
• Scientific title: Terlipressin versus albumin in the prevention of paracentesis associated adverse events in patients with cirrhosis and tense ascites. A multicenter randomised controlled trial. - TAPP-study
• Date of first enrolment: 1/12/2005
• Target sample size: 84
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=463
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: J.J. Kuiper

• Name: J.J. Kuiper

Key inclusion & exclusion criteria

Inclusion criteria: 1. Cirrhosis with tense ascites requiring therapeutic paracentesis;

2. Age 18-70;

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:

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Liver cirrhosis, Ascites

Intervention(s)

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 of 1 mg terlipressin at onset of therapeutic paracentesis and another iv-bolus of 2 mg 6 hours after paracentesis.
The albumin group will receive 8 gr of albumin iv per liter of ascitic fluid removed.
At onset, after 6 hours, and on day 6 after paracentesis vital functions, blood, urine, and ascitic fluid samples will be taken to measure the effect of the medication.

Primary Outcome(s)

Decrease in EABV. This is an increase in plasma renin concentration (PRC) of more than 50% of baseline values 6 days after paracentesis.

Secondary Outcome(s)

1. Circulatory parameters;

2. Renal function;

3. Bodyweight (recurrence of ascites);

4. Adverse events;

5. Costs.

Secondary ID(s)

ISRCTN36383299

N/A

Source(s) of Monetary Support

Foundation for Liver Research (SLO), Erasmus Medical Center, Dutch Society for Hepatology (NVH)