Noradrenalin vs Terlipressin in Hepatorenal Syndrome

Phase 3

Completed

• Conditions: Hepatorenal Syndrome
• Interventions: Drug: Terlipressin; Drug: Noradrenalin

• Registration Number: NCT00370253
• Lead Sponsor: University of Turin, Italy

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 Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-08-31
• Study Start: 2006-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-09
• Last Update Posted: 2008-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Terlipressin	Terlipressin
1	Noradrenalin	Noradrenalin

Primary Outcome Measures

Name	Time	Method
Renal function at the beginning and at the end of therapy	two weeks

Secondary Outcome Measures

Name	Time	Method
Circulatory function	two weeks

Trial Locations

Locations (1)

San Giovanni Battista Hospital; 🇮🇹 Turin, Italy