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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Padova
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00742690
First received: August 26, 2008
Last updated: October 11, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Cirrhosis
Type 1 Hepatorenal Syndrome
Drug: terlipressin given by intravenous boluses and albumin
Drug: terlipressin given by continuous intravenous infusion and albumin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: May 2005
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
35 patients with cirrhosis and type 1 HRS
Drug: terlipressin given by intravenous boluses and albumin
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.
Experimental: 2
35 patients with cirrhosis and type 1 HRS
Drug: terlipressin given by continuous intravenous infusion and albumin
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742690

Contacts
Contact: Alessandra Galioto, MD alegalioto@unipd.it

Locations
Italy
Liver Unit, General Hospital Recruiting
Padova, Italy, 35100
Sub-Investigator: Giulio Maresio, MD         
Sponsors and Collaborators
University of Padova
  More Information

Publications:
Responsible Party: Clinica Medica 5, Univeristy of Padova
ClinicalTrials.gov Identifier: NCT00742690     History of Changes
Other Study ID Numbers: 1442P
Study First Received: August 26, 2008
Last Updated: October 11, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University of Padova:
cirrhosis
type 1 hepatorenal syndrome
terlipressin
albumin
effective circulating volume
Patients
with

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Cirrhosis
Syndrome
Digestive System Diseases
Disease
Kidney Diseases
Liver Diseases
Pathologic Processes
Urologic Diseases
Lypressin
Terlipressin
Antidiuretic Agents
Antihypertensive Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 21, 2014