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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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ClinicalTrials.gov Identifier: NCT00742690
Recruitment Status : Unknown
Verified October 2014 by University of Padova.
Recruitment status was:  Recruiting
First Posted : August 28, 2008
Last Update Posted : October 15, 2014
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2005
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Clinica Medica 5, Univeristy of Padova
ClinicalTrials.gov Identifier: NCT00742690     History of Changes
Other Study ID Numbers: 1442P
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

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

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