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Noradrenalin vs Terlipressin in Hepatorenal Syndrome

NCT ID: NCT00370253

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Hepatorenal Syndrome

Keywords

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hepatorenal syndrome ascites portal hypertension cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

Terlipressin

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

1mg/4 h per day

1

Noradrenalin

Group Type EXPERIMENTAL

Noradrenalin

Intervention Type DRUG

0,1 mcg/kg/min

Interventions

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Terlipressin

1mg/4 h per day

Intervention Type DRUG

Noradrenalin

0,1 mcg/kg/min

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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University of Turin

Principal Investigators

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Mario Rizzetto, MD

Role: STUDY_DIRECTOR

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

Locations

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San Giovanni Battista Hospital

Turin, , Italy

Site Status

Countries

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Italy

References

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Ortega R, Gines P, Uriz J, Cardenas A, Calahorra B, De Las Heras D, Guevara M, Bataller R, Jimenez W, Arroyo V, Rodes J. Terlipressin therapy with and without albumin for patients with hepatorenal syndrome: results of a prospective, nonrandomized study. Hepatology. 2002 Oct;36(4 Pt 1):941-8. doi: 10.1053/jhep.2002.35819.

Reference Type BACKGROUND
PMID: 12297842 (View on PubMed)

Duvoux C, Zanditenas D, Hezode C, Chauvat A, Monin JL, Roudot-Thoraval F, Mallat A, Dhumeaux D. Effects of noradrenalin and albumin in patients with type I hepatorenal syndrome: a pilot study. Hepatology. 2002 Aug;36(2):374-80. doi: 10.1053/jhep.2002.34343.

Reference Type BACKGROUND
PMID: 12143045 (View on PubMed)

Alessandria C, Ottobrelli A, Debernardi-Venon W, Todros L, Cerenzia MT, Martini S, Balzola F, Morgando A, Rizzetto M, Marzano A. Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study. J Hepatol. 2007 Oct;47(4):499-505. doi: 10.1016/j.jhep.2007.04.010. Epub 2007 May 24.

Reference Type DERIVED
PMID: 17560680 (View on PubMed)

Other Identifiers

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NA-TER

Identifier Type: -

Identifier Source: org_study_id