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Noradrenalin vs Terlipressin in Hepatorenal Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00370253
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : April 11, 2008
Sponsor:
Information provided by:
University of Turin, Italy

Tracking Information
First Submitted Date  ICMJE August 30, 2006
First Posted Date  ICMJE August 31, 2006
Last Update Posted Date April 11, 2008
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
Renal function at the beginning and at the end of therapy [ Time Frame: two weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2006)
Renal function at the beginning and at the end of therapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
Circulatory function [ Time Frame: two weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2006)
Circulatory function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Noradrenalin vs Terlipressin in Hepatorenal Syndrome
Official Title  ICMJE Noradrenalin vs Terlipressin in Patients With Hepatorenal Syndrome.A Prospective, Randomized Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatorenal Syndrome
Intervention  ICMJE
  • Drug: Terlipressin
    1mg/4 h per day
  • Drug: Noradrenalin
    0,1 mcg/kg/min
Study Arms  ICMJE
  • Active Comparator: 2
    Terlipressin
    Intervention: Drug: Terlipressin
  • Experimental: 1
    Noradrenalin
    Intervention: Drug: Noradrenalin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00370253
Other Study ID Numbers  ICMJE NA-TER
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Rizzetto, University of Turin
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mario Rizzetto, MD Division of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy
PRS Account University of Turin, Italy
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP