Text Size

Single Pass Albumin Dialysis in Patients With Cirrhosis (DACAR)

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00764049
First received: September 30, 2008
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cirrhosis Dialysis
U.S. FDA Resources

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 ]

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.
Other Name: Single pass 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

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: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00764049     History of Changes
Other Study ID Numbers: P050902
Study First Received: September 30, 2008
Last Updated: February 13, 2013
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Liver Failure
Liver Failure, Acute
End Stage Liver Disease
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
 Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Hepatic Insufficiency
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on May 23, 2013