Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin - Tabular View

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Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

This study has been suspended.
Information provided by Hospital Clinic of Barcelona

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Official Title ^†

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 Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Primary Outcome Measure ^†

Survival

Secondary Outcome Measure ^†

Condition ^†

Cirrhosis
Hepatorenal Syndrome

Intervention ^†

Drug: terlipressin

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Suspended

Enrollment ^†

100

Start Date ^†

February 2002

Completion Date

September 2006

Eligibility Criteria ^†

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 ^††

Location Countries ^†

Spain

Administrative Information Fields

NCT ID ^†

NCT00287664

Organization ID

TAHRS

Secondary IDs ^††

Study Sponsor ^†

Hospital Clinic of Barcelona

Collaborators ^††

Grant from Education Ministery from 2001-2004.

Investigators ^†

Principal Investigator:

Pere Gines, MD

Chair of Liver Unit

Information Provided By

Hospital Clinic of Barcelona

Verification Date

April 2007

First Received Date ^†

February 3, 2006

Last Updated Date

April 10, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.