COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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The efficacy of terlipressin in comparison with albumin in the prevention of circulatory changes after the paracentesis of tense ascites--a randomized multicentric study.

BACKGROUND/AIMS: Postparacentesis circulatory dysfunction is the most severe complication of ascites paracentesis. The aim of our study was to compare the standard treatment with the administration of a vasoconstrictor terlipressin.

METHODOLOGY: Forty-nine patients treated by paracentesis due to tense ascites were randomized for the treatment with albumin (8g/L of removed ascites) or terlipressin (1 mg every four hours for 48 hours). The blood pressure, heart rate, diuresis, electrocardiograph, standard biochemical and hematological parameters, sodium, potassium and nitrogen urinary excretion, aldosterone and renin activity in the blood plasma were monitored for a period of 72 hours.

RESULTS: In any parameter of hemodynamic changes, no statistically significant difference was demonstrated between randomized groups, in particular measurements as well as in the development in the course of the first three days after the intervention. The result suggests similar efficacy of the circulatory dysfunction prevention after the paracentesis in both treatment procedures. In both groups, on the first three days, there was a tendency to improve hemodynamics reflected by the renin-angiotensin-aldosteron system activity. In the terlipressin group, this tendency approached statistically significant levels.

CONCLUSIONS: The administration of terlipressin in a dose of 1 mg every fourth hour performed for a period of 48 hours was as effective as intravenous albumin in preventing hemodynamic changes in patients with tense ascites treated by paracentesis. The treatment was well tolerated.

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