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Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

This study has suspended participant recruitment.
(because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287664
First Posted: February 7, 2006
Last Update Posted: April 11, 2007
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.
Collaborator:
Grant from Education Ministery from 2001-2004.
Information provided by:
Hospital Clinic of Barcelona
  Purpose
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 Intervention Phase
Cirrhosis Hepatorenal Syndrome Drug: terlipressin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Survival

Estimated Enrollment: 100
Study Start Date: February 2002
Estimated Study Completion Date: September 2006
Detailed Description:
Phase 3
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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
Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Grant from Education Ministery from 2001-2004.
Investigators
Principal Investigator: Pere Gines, MD Chair of Liver Unit
  More Information

ClinicalTrials.gov Identifier: NCT00287664     History of Changes
Other Study ID Numbers: TAHRS
First Submitted: February 3, 2006
First Posted: February 7, 2006
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:
Syndrome
Fibrosis
Liver Cirrhosis
Hepatorenal Syndrome
Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Terlipressin
Lypressin
Antihypertensive Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs