drugset / Trial / NCT00742690

Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome

NCT00742690

Phase 2/3 Unknown 70 enrolled University of Padova
RandomizedParallel-groupOpen-labelTreatment

Summary

It is well known that terlipressin and albumin improve renal function in patients with cirrhosis and type 1 HRS. In previous studies terlipressin has been used either as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr or as continuous intravenous infusion at the initial dose of 2 mg/24 h. Up to now the two schedules of i.v. administration of terlipressin have never been compared. Nevertheless, it has been hypothesized that continuous intravenous infusion assures a more steady profile of effect on portal pressure in patients with cirrhosis. Thus, the aim of the study will be to compare terlipressin given as i.v. bolus vs terlipressin given as continuous intravenous infusion in the treatment of type 1 HRS in patients with cirrhosis.

Timeline

Start
2005-05
Primary completion
2014-12
Completion
2015-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Terlipressin Peptide 2 mg Intravenous
Comparator Albumin Protein / enzyme biologic 20 g Intravenous
Comparator Albumin Protein / enzyme biologic 40 g Intravenous