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| Sponsor: | University of Turin, Italy |
|---|---|
| Information provided by: | University of Turin, Italy |
| ClinicalTrials.gov Identifier: | NCT00370253 |
Purpose
The purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatorenal Syndrome |
Drug: Terlipressin Drug: Noradrenalin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study |
| Enrollment: | 20 |
| Study Start Date: | September 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
Terlipressin
|
Drug: Terlipressin
1mg/4 h per day
|
|
Experimental: 1
Noradrenalin
|
Drug: Noradrenalin
0,1 mcg/kg/min
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| San Giovanni Battista Hospital | |
| Turin, Italy, 10126 | |
| Study Director: | Mario Rizzetto, MD | Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy |
More Information
| Responsible Party: | Mario Rizzetto, University of Turin |
| ClinicalTrials.gov Identifier: | NCT00370253 History of Changes |
| Other Study ID Numbers: | NA-TER |
| Study First Received: | August 30, 2006 |
| Last Updated: | April 9, 2008 |
| Health Authority: | Italy: Ministry of Health |
|
hepatorenal syndrome ascites portal hypertension cirrhosis |
|
Hepatorenal Syndrome Liver Diseases Digestive System Diseases Kidney Diseases Urologic Diseases Norepinephrine Terlipressin Lypressin Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents |
Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Antidiuretic Agents Natriuretic Agents Hemostatics Coagulants Hematologic Agents |