Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

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. 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
Grant from Education Ministery from 2001-2004.
Information provided by:
Hospital Clinic of Barcelona

February 3, 2006
February 7, 2006
April 11, 2007
February 2002
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Same as current
Complete list of historical versions of study NCT00287664 on 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
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cirrhosis
  • Hepatorenal Syndrome
Drug: terlipressin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2006
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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 )
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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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