Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370253
Status:
COMPLETED
Last Update Posted:
2008-04-11
First Post:
2006-08-30
Brief Title:
Noradrenalin vs Terlipressin in Hepatorenal Syndrome
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Noradrenalin vs Terlipressin in Patients With Hepatorenal SyndromeA Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 rateAmong 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None