Terlipressin Given As I.V. Boluses Vs Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome (Hrs): Preliminary Results Of A Randomized Controlled Clinical Study.

NCT00742690 Phase 2/Phase 3 UNKNOWN

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.

Details

Lead sponsor	University of Padova
Phase	Phase 2/Phase 3
Status	UNKNOWN
Enrolment	70
Start date	2005-05
Completion	2015-03

Conditions

• Cirrhosis
• Type 1 Hepatorenal Syndrome

Interventions

• terlipressin given by intravenous boluses and albumin
• terlipressin given by continuous intravenous infusion and albumin

Primary outcomes

• The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl). — The treatment will be continued for a maximum of 15 days

Countries

Italy