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Single Pass Albumin Dialysis in Patients With Cirrhosis (DACAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764049
First Posted: October 1, 2008
Last Update Posted: February 25, 2015
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.
Collaborators:
Laboratoire français de Fractionnement et de Biotechnologies
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Condition Intervention Phase
Cirrhosis Acute on Chronic Hepatic Failure Hepatorenal Syndrome Encephalopathy Device: Single pass albumin dialysis Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 3 months ]

Enrollment: 11
Study Start Date: June 2009
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Single pass albumin dialysis
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764049


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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00764049     History of Changes
Other Study ID Numbers: P050902
First Submitted: September 30, 2008
First Posted: October 1, 2008
Last Update Posted: February 25, 2015
Last Verified: February 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Albumin dialysis
Artificial liver support
Acute on chronic liver failure

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Brain Diseases
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Hepatorenal Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Hepatic Insufficiency
Liver Failure, Acute
Kidney Diseases
Urologic Diseases