Single Pass Albumin Dialysis in Patients With Cirrhosis - Full Text View

Single Pass Albumin Dialysis in Patients With Cirrhosis (DACAR)

This study is not yet open for participant recruitment.

Verified by Assistance Publique - Hôpitaux de Paris, September 2008

First Received: September 30, 2008 Last Updated: December 1, 2008 History of Changes

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Laboratoire français de Fractionnement et de Biotechnologies Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00764049

Purpose

The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Condition	Intervention	Phase
Acute on Chronic Liver Failure Cirrhosis Encephalopathy Hepatorenal Syndrome	Device: Single pass albumin dialysis	Phase I Phase II

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Efficacy Study, Open Label, Single Group Assignment, Treatment, Uncontrolled
Official Title:	Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Effects on clinical and biochemical variables [ Time Frame: 3 months follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients entered in the pilot study	Device: Single pass albumin dialysis 6 hours sessions of albumin dialysis.

Detailed Description:

Albumin dialysis has beneficial effects in patients with acute on chronic liver failure. However, current devices are complex and costly. The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Minimum age of 18 years
Written consent after information of the patient or, in case of inability, by a parent or a close if he is present.
Patient having a cirrhosis researched by previous exams (liver biopsy) or, in the absence of previous diagnosis, diagnosed in view of the results of clinical, biological and morphological data, whatever the origin of the cirrhosis (virus of hepatitis B, virus of hepatitis C, extreme consumption of alcohol or other reasons)

Exclusion Criteria:

Participation to an other study in the 4 weeks before
Active digestive bleeding, unchecked by the pharmacological treatments and the endoscopic techniques.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764049

Contacts

Contact: François DURAND, PU PH

+33(0) 1 40 87 50 91

francois.durand@bjn.ap-hop-paris.fr

Locations

France
Hôpital Beaujon
Clichy, France, 92110

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Laboratoire français de Fractionnement et de Biotechnologies

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator:

François Durand, Pr

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department Clinical Research of Developpement ( Yannick Vacher )
Study ID Numbers:	P050902
Study First Received:	September 30, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00764049 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Acute on chronic liver failure
Albumin dialysis
Artificial liver support

Study placed in the following topic categories:

Liver Failure
Liver Diseases
Digestive System Diseases
Urologic Diseases
Fibrosis

Kidney Diseases
Liver Cirrhosis
Hepatorenal Syndrome
Hepatic Insufficiency

Additional relevant MeSH terms:

Liver Failure
Liver Diseases
Disease
Pathologic Processes
Digestive System Diseases
Urologic Diseases

Fibrosis
Syndrome
Kidney Diseases
Liver Cirrhosis
Hepatorenal Syndrome
Hepatic Insufficiency

ClinicalTrials.gov processed this record on March 16, 2009