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Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

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ClinicalTrials.gov Identifier: NCT00287664
Recruitment Status : Suspended (because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.)
First Posted : February 7, 2006
Last Update Posted : April 11, 2007
Sponsor:
Collaborator:
Grant from Education Ministery from 2001-2004.
Information provided by:
Hospital Clinic of Barcelona

Study Description
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Brief Summary:
Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.

Condition or disease Intervention/treatment Phase
Cirrhosis Hepatorenal Syndrome Drug: terlipressin Phase 4

Detailed Description:
Phase 3
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study
Study Start Date : February 2002
Study Completion Date : September 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Survival

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL
  2. Age between 18 and 75 years
  3. Written informed consent.
  4. Absence of exclusion criteria

Exclusion Criteria:

  1. Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
  2. Active infection with systemic inflammatory response syndrome
  3. Respiratory or cardiac dysfunction.
  4. Arteriopathy.
  5. Ischemic cardiopathy.
  6. Arterial hypertension ( >140/90 mmHg during hospitalization )
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287664


Locations
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Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Grant from Education Ministery from 2001-2004.
Investigators
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Principal Investigator: Pere Gines, MD Chair of Liver Unit
More Information
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ClinicalTrials.gov Identifier: NCT00287664    
Other Study ID Numbers: TAHRS
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: April 2007
Keywords provided by Hospital Clinic of Barcelona:
hepatorenal syndrome
terlipressin
albumin
cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatorenal Syndrome
Syndrome
Fibrosis
Disease
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Kidney Diseases
Urologic Diseases
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents