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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2006

Last Updated Date

April 10, 2007

Start Date ^ICMJE

February 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00287664 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Official Title ^ICMJE

Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study

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.

Detailed Description

Phase 3

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cirrhosis
Hepatorenal Syndrome

Intervention ^ICMJE

Drug: terlipressin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

100

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
Active infection with systemic inflammatory response syndrome
Respiratory or cardiac dysfunction.
Arteriopathy.
Ischemic cardiopathy.
Arterial hypertension ( >140/90 mmHg during hospitalization )

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00287664

Other Study ID Numbers ^ICMJE

TAHRS

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hospital Clinic of Barcelona

Collaborators ^ICMJE

Grant from Education Ministery from 2001-2004.

Investigators ^ICMJE

Principal Investigator:

Pere Gines, MD

Chair of Liver Unit

Information Provided By

Hospital Clinic of Barcelona

Verification Date

April 2007

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

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