|- candidate number||1781|
|- NTR Number||NTR463|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||24-okt-2005|
|- Secondary IDs||N/A |
|- 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.|
|- hypothesis||The 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) studied||Liver cirrhosis, Ascites|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2005|
|- planned closingdate||30-nov-2006|
|- Target number of participants||84|
|- 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 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||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||1. Circulatory parameters;|
2. Renal function;
3. Bodyweight (recurrence of ascites);
4. Adverse events;
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. MD. J.J. Kuiper|
|- CONTACT for SCIENTIFIC QUERIES||Drs. MD. J.J. Kuiper|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Hepatology and Gastroenterology|
(Source(s) of Monetary or Material Support)
|Foundation for Liver Research (SLO), Erasmus Medical Center, Dutch Society for Hepatology (NVH)|
|- Brief summary||Patients 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)|
|- RECORD||24-okt-2005 - 14-sep-2009|