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

Phase 2

• Conditions: Cirrhosis; Type 1 Hepatorenal Syndrome
• Interventions: Drug: terlipressin given by continuous intravenous infusion and albumin; Drug: terlipressin given by intravenous boluses and albumin

• Registration Number: NCT00742690
• Lead Sponsor: University of Padova

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-11
• Last Update Posted: 2014-10-15
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	terlipressin given by continuous intravenous infusion and albumin	35 patients with cirrhosis and type 1 HRS
1	terlipressin given by intravenous boluses and albumin	35 patients with cirrhosis and type 1 HRS

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Liver Unit, General Hospital; 🇮🇹 Padova, Italy