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Single Pass Albumin Dialysis in Patients With Cirrhosis (DACAR)

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ClinicalTrials.gov Identifier: NCT00764049
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : February 25, 2015
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

September 30, 2008
October 1, 2008
February 25, 2015
June 2009
January 2012   (Final data collection date for primary outcome measure)
Effects on clinical and biochemical variables [ Time Frame: 3 months follow-up ]
Same as current
Complete list of historical versions of study NCT00764049 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Single Pass Albumin Dialysis in Patients With Cirrhosis
Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure
The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.
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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cirrhosis
  • Acute on Chronic Hepatic Failure
  • Hepatorenal Syndrome
  • Encephalopathy
Device: Single pass albumin dialysis
6 hours sessions of albumin dialysis.
Experimental: 1: Single pass albumin dialysis
Patients entered in the pilot study.
Intervention: Device: Single pass albumin dialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
20
July 2012
January 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00764049
P050902
Yes
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
  • Laboratoire français de Fractionnement et de Biotechnologies
  • Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: François Durand, Pr Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP