- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00370253
Noradrenalin vs Terlipressin in Hepatorenal Syndrome
April 9, 2008 updated by: University of Turin, Italy
Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study
The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Turin, Italy, 10126
- San Giovanni Battista Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Terlipressin
|
1mg/4 h per day
|
Experimental: 1
Noradrenalin
|
0,1 mcg/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Renal function at the beginning and at the end of therapy
Time Frame: two weeks
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Circulatory function
Time Frame: two weeks
|
two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mario Rizzetto, MD, Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
August 30, 2006
First Submitted That Met QC Criteria
August 30, 2006
First Posted (Estimate)
August 31, 2006
Study Record Updates
Last Update Posted (Estimate)
April 11, 2008
Last Update Submitted That Met QC Criteria
April 9, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease
- Liver Diseases
- Syndrome
- Hepatorenal Syndrome
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
- Terlipressin
Other Study ID Numbers
- NA-TER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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