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

NCT00742690 | Unknown Phase 2

• 1 other identifier: 1442P
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Type 1 Hepatorenal Syndrome

Keywords

cirrhosis; type 1 hepatorenal syndrome; terlipressin; albumin; effective circulating volume; Patients; with

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

35 patients with cirrhosis and type 1 HRS

Drug: terlipressin given by intravenous boluses and albumin

2

EXPERIMENTAL

35 patients with cirrhosis and type 1 HRS

Drug: terlipressin given by continuous intravenous infusion and albumin

Interventions

terlipressin given by intravenous boluses and albumin DRUG

Patients who will be randomly assigned to arm 1 will received terlipressin given by intravenous boluses at the initial dose of terlipressin was 0.5 mg/4 hr. In case of non response, the dose of terlipressin was progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given intravenously at the dose of 1 g/kg of body weight on the first day followed by 20-40 g/day.

1

terlipressin given by continuous intravenous infusion and albumin DRUG

Patients who will be randomly assigned to arm 1 will received terlipressin given as intravenous boluses at the initial dose of 0.5 mg/4 hr. In case of non response, the dose of terlipressin will be progressively increased up to a maximum of 2 mg/4 hr. Human albumin will be given at the dose of 1 g/kg of body weight at the first day followed by 20-40 g/day.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cirrhosis and type 1 HRS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Liver Unit, General Hospital

Padua, 35100, Italy

RECRUITING

Related Publications (1)

• Angeli P, Guarda S, Fasolato S, Miola E, Craighero R, Piccolo F, Antona C, Brollo L, Franchin M, Cillo U, Merkel C, Gatta A. Switch therapy with ciprofloxacin vs. intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis: similar efficacy at lower cost. Aliment Pharmacol Ther. 2006 Jan 1;23(1):75-84. doi: 10.1111/j.1365-2036.2006.02706.x.

  PMID: 16393283 RESULT

MeSH Terms

Conditions

Fibrosis

Interventions

Albumins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Alessandra Galioto, MD

CONTACT

alegalioto@unipd.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: May 1, 2005
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

IT (1)