A Phase 3 interventional study of Terlipressin and Placebo in Cirrhosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-15.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first step treatment. Refractory ascites (not responding to first step treatment) is treated with repeated large volume paracentesis followed by intra venous albumin expansion. In pilot studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites production. Therefore the investigators will study the effect of combined therapy with albumin and terlipressin on recidivation ascites.
About 30% of cirrhotic patients will develop ascites. Sodium restriction and diuretics are the first step treatment. Total paracentesis is used in patients with cirrhosis and tense ascites. Paracentesis alone was found to induce a decrease in effective arterial blood volume. This circulatory dysfunction may induce inhospital complications such as impaired renal function or hyponatremia and is associated with a significant reduction in long term survival. Intravenous albumin administration after paracentesis has been shown to prevent the post paracentesis decrease in arterial blood volume. Paracentesis also induces arteriolar vasodilation which plays a major role in initiating the decrease in arterial blood volume. Therefore, administration of a vasoconstrictor may decrease paracentesis induced arteriolar vasodilation and prevent the resulting decrease in effective arterial blood volume. Two randomised pilot studies suggest that Terlipressin may be as effective as intravenous albumin in preventing a decrease in effective arterial blood volume in patients with cirrhosis treated by paracentesis for tense ascites. The combined treatment, albumin plus terlipressin, could have additional effect and may improve ascites in such patients. In several studies the combined therapy, albumin plus terlipressin, has shown beneficial effect in cirrhotic patients with hepatorenal syndrome characterized by a sever decrease in arterial blood volume and vasodilation. In these studies, combined therapy was well tolerated.The aim of this study is to compare ascites relapse between two groups of cirrhotic patients with recidivation ascites treated by paracentesis and intravenous albumin perfusion plus terlipressin or placebo. In this double blind randomized multi-center trial, all patients receive albumin perfusion at the dose 8 g/l of removed ascites and Terlipressin (1mg) or placebo, administrated before and at the end of the paracentesis.
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Exclusion Criteria:
Drug: Terlipressin
Drug: Placebo
Albumin perfusions at the dose 8 g/l of removed ascites and Terlipressin (1mg), administrated before and at the end of the paracentesis.
albumin perfusion at the dose 8 g/l of removed ascites and placebo, administrated before and at the end of the paracentesis.
Mean number of paracentesis between the 2 groups over a 6 months period
Time frame: 6 months
Total ascites retrieval
Time frame: 6 months
Number of cirrhosis complications groups
Time frame: 6 months
Liver transplantation and deaths
Time frame: 6 months
Terlipressin safety
Time frame: 6 months
Mean number of days of hospitalization
Time frame: 6 months
Delay between inclusion and the first rehospitalisation for ascites retrieval
Time frame: 6 months
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris