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

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.

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.

N/A

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.