Terlipressin versus albumin in the prevention of paracentesis-associated adverse events in patients with cirrhosis and tense ascites

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: Patients will be randomly assigned to receive either terlipressin or albumin, the standard treatment, intravenously (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 g of albumin iv per litre 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. CONDITION: Cirrhosis of the liver/ascites ; Digestive System ; Fibrosis and cirrhosis of liver 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. Body weight (recurrence of ascites); 4. Adverse events; 5. Costs INCLUSION CRITERIA: 1. Cirrhosis with tense ascites requiring therapeutic paracentesis 2. Aged 18 ‐ 70 years 3. Written informed consent
Epistemonikos ID: 25e6039e9f5a5577301f722b52efcbc6679132e3
First added on: Aug 21, 2024