Noradrenalin vs Terlipressin in Hepatorenal Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2006

Last Updated Date

April 9, 2008

Start Date ^ICMJE

September 2006

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Renal function at the beginning and at the end of therapy [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Renal function at the beginning and at the end of therapy

Change History

Complete list of historical versions of study NCT00370253 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Circulatory function [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Circulatory function

Descriptive Information

Brief Title ^ICMJE

Noradrenalin vs Terlipressin in Hepatorenal Syndrome

Official Title ^ICMJE

Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study

Brief Summary

The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome

Detailed Description

Hepatorenal syndrome (HRS) is a major complication of cirrhosis; it is characterized by functional renal failure and poor prognosis. Arterial dilation is a key pathogenic event of HRS, leading to reduction of the effective blood volume, homeostatic activation of vasoactive systems and renal vasoconstriction with decrease in renal blood flow. The clinical signs of HRS vary depending on the clinical pattern. HRS type 1 is characterized by a rapidly progressive renal failure; HRS type 2 by a moderate and more stable renal failure. HRS type 1 has a very poor short term prognosis, with a median survival of only about 2 weeks; patients with HRS type 2 have a median survival of about 6 months. The management of HRS still constitutes a major challenge. Liver transplantation is the ideal treatment, but it has important inherent drawbacks, such as the organ shortage and the time needed to perform the transplant, that is too long to consent the survival of these patients. The management of HRS has focused on improving renal function, thus extending patients survival and allowing the performance of the liver transplant. In the last years, remarkable results have been obtained using vasoconstrictor drugs. By improving the effective blood volume, vasoconstrictors induce the suppression of homeostatic vasoactive systems and increase renal blood flow and glomerular filtration rate.Among vasoconstrictors, terlipressin, a V1 vasopressin agonist, has currently the best efficacy pedigree. However, it is expensive and is not available in many countries, including North America. More recently, it was suggested that alpha-adrenergic drugs such noradrenalin and midodrine may be also effective in HRS. Noradrenalin would have the potential advantage of wider availability and of lower cost. The current prospective randomized study was undertaken to assess the efficacy and safety of noradrenalin vs terlipressin in patients with HRS.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatorenal Syndrome

Intervention ^ICMJE

Drug: Terlipressin
Drug: Noradrenalin

Study Arms / Comparison Groups

Active Comparator: Terlipressin
Experimental: Noradrenalin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Hepatorenal syndrome
Age: 18-75 years
Informed written consent

Exclusion Criteria:

Multinodular hepatocellular carcinoma (more than 3 nodules)
Portal vein thrombosis
Ongoing bacterial infection
Ongoing or recent (less than one week) bleeding
Cardio-pulmonary failure
Coronary artery disease
Peripheral artery disease
Arterial hypertension

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00370253

Responsible Party

Mario Rizzetto, University of Turin

Study ID Numbers ^ICMJE

NA-TER

Study Sponsor ^ICMJE

University of Turin, Italy

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Mario Rizzetto, MD

Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy

Information Provided By

University of Turin, Italy

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP