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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:
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

February 3, 2006
April 10, 2007
February 2002
Not Provided
Survival
Same as current
Complete list of historical versions of study NCT00287664 on ClinicalTrials.gov Archive Site
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Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study

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.

Phase 3

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cirrhosis
  • Hepatorenal Syndrome
Drug: terlipressin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
100
September 2006
Not Provided

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 )
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00287664
TAHRS
Not Provided
Not Provided
Hospital Clinic of Barcelona
Grant from Education Ministery from 2001-2004.
Principal Investigator: Pere Gines, MD Chair of Liver Unit
Hospital Clinic of Barcelona
April 2007

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