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

University of Padova

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Cirrhosis

Type 1 Hepatorenal Syndrome

Treatments

Drug: terlipressin given by intravenous boluses and albumin

Drug: terlipressin given by continuous intravenous infusion and albumin

Study type

Interventional

Funder types

Other

Identifiers

NCT00742690

1442P

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with cirrhosis and type 1 HRS

Exclusion criteria

HCC beyond the Milan Criteria,septic shock (systolic arterial pressure < 90 mmHg,
Significant heart or respiratory failure,
Peripheral arteriophaty clinically significant,
Previous heart stroke or significant alteration of the ECG