Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin - Full Text View

Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

This study has been suspended.
( because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point. )

Sponsors and Collaborators:	Hospital Clinic of Barcelona Grant from Education Ministery from 2001-2004.
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00287664

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 IV

Genetics Home Reference related topics:

Kidney Diseases

MedlinePlus related topics:

Cirrhosis

ChemIDplus related topics:

Terlipressin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

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

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:

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 )

Contacts and Locations

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

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

Keywords provided by Hospital Clinic of Barcelona:

hepatorenal syndrome

terlipressin

albumin

cirrhosis

Study placed in the following topic categories:

Hepatorenal syndrome

Liver Diseases

Fibrosis

Terlipressin

Kidney Diseases

Liver Cirrhosis

Hepatorenal Syndrome

Additional relevant MeSH terms:

Disease

Pathologic Processes

Digestive System Diseases

Urologic Diseases

Therapeutic Uses

Syndrome

Vasoconstrictor Agents

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008