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:
Collaborator:
Grant from Education Ministery from 2001-2004.
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00287664
First received: February 3, 2006
Last updated: April 10, 2007
Last verified: April 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00287664     History of Changes
Other Study ID Numbers: TAHRS
Study First Received: February 3, 2006
Last Updated: April 10, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
hepatorenal syndrome
terlipressin
albumin
cirrhosis

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Pathologic Processes
Terlipressin
Lypressin
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on July 20, 2014