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


- candidate number1781
- NTR NumberNTR463
- ISRCTNISRCTN36383299
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR24-okt-2005
- Secondary IDsN/A 
- Public TitleTerlipressin versus albumin in the prevention of paracentesis associated adverse events in patients with cirrhosis and tense ascites. A multicenter randomised controlled trial.
- Scientific TitleTerlipressin versus albumin in the prevention of paracentesis associated adverse events in patients with cirrhosis and tense ascites. A multicenter randomised controlled trial.
- ACRONYMTAPP-study
- hypothesisThe effect of terlipressin on the effective arterial blood volume (EABV) in patients with cirrhosis and (tense) ascites who receive a therapeutic paracentesis, is equivalent to the current standard treatment with human albumin without the risks of a bloodproduct and with lower costs.
- Healt Condition(s) or Problem(s) studiedLiver cirrhosis, Ascites
- Inclusion criteria1. Cirrhosis with tense ascites requiring therapeutic paracentesis;
2. Age 18-70;
3. Written informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2005
- planned closingdate30-nov-2006
- Target number of participants84
- InterventionsPatients 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 outcomeDecrease in EABV. This is an increase in plasma renin concentration (PRC) of more than 50% of baseline values 6 days after paracentesis.
- Secondary outcome1. Circulatory parameters;
2. Renal function;
3. Bodyweight (recurrence of ascites);
4. Adverse events;
5. Costs.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. MD. J.J. Kuiper
- CONTACT for SCIENTIFIC QUERIESDrs. MD. J.J. Kuiper
- Sponsor/Initiator Erasmus Medical Center, Department of Hepatology and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Foundation for Liver Research (SLO), Erasmus Medical Center, Dutch Society for Hepatology (NVH)
- PublicationsN/A
- Brief summaryPatients with cirrhosis and (tense) ascites requiring therapeutic paracentesis can be enrolled. They will be randomly assigned to receive either terlipressin or, the standard treatment, albumin iv for suppletion with paracentesis.
It will be studied whether terlipressin gives an equivalent prevention of decrease in effective arterial blood volume as albumin does in this setting.
Time points of this trial, when parameters will be taken, are at onset of paracentesis, 6 hours after, and 6 days after paracentesis. The safety follow-up will be for a duration of 2 months after which the patient can re-enter the study once. He or she will then automatically be placed in the other arm.
- Main changes (audit trail)
- RECORD24-okt-2005 - 14-sep-2009


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