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

Primary Purpose

Cirrhosis, Type 1 Hepatorenal Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
terlipressin given by intravenous boluses and albumin
terlipressin given by continuous intravenous infusion and albumin
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring cirrhosis, type 1 hepatorenal syndrome, terlipressin, albumin, effective circulating volume, Patients, with

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Liver Unit, General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

35 patients with cirrhosis and type 1 HRS

35 patients with cirrhosis and type 1 HRS

Outcomes

Primary Outcome Measures

The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl).

Secondary Outcome Measures

Full Information

First Posted
August 26, 2008
Last Updated
October 11, 2014
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT00742690
Brief Title
Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Padova

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Type 1 Hepatorenal Syndrome
Keywords
cirrhosis, type 1 hepatorenal syndrome, terlipressin, albumin, effective circulating volume, Patients, with

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
35 patients with cirrhosis and type 1 HRS
Arm Title
2
Arm Type
Experimental
Arm Description
35 patients with cirrhosis and type 1 HRS
Intervention Type
Drug
Intervention Name(s)
terlipressin given by intravenous boluses and albumin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
terlipressin given by continuous intravenous infusion and albumin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary end-point of the study is the complete reform of the renal function (creatinine < 1.5 mg/dl).
Time Frame
The treatment will be continued for a maximum of 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Galioto, MD
Email
alegalioto@unipd.it
Facility Information:
Facility Name
Liver Unit, General Hospital
City
Padova
ZIP/Postal Code
35100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Maresio, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16393283
Citation
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.
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Terlipressin Given As I.V. Boluses Versus Terlipressin Given As Continuous Intravenous Infusion In Patients With Cirrhosis And Type 1 Hepatorenal Syndrome

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