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Single Pass Albumin Dialysis in Patients With Cirrhosis (DACAR)

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date February 25, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
Effects on clinical and biochemical variables [ Time Frame: 3 months follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
Safety [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Pass Albumin Dialysis in Patients With Cirrhosis
Official Title  ICMJE Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure
Brief Summary The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cirrhosis
  • Acute on Chronic Hepatic Failure
  • Hepatorenal Syndrome
  • Encephalopathy
Intervention  ICMJE Device: Single pass albumin dialysis
6 hours sessions of albumin dialysis.
Study Arms  ICMJE Experimental: 1: Single pass albumin dialysis
Patients entered in the pilot study.
Intervention: Device: Single pass albumin dialysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2012)
11
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
20
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764049
Other Study ID Numbers  ICMJE P050902
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE
  • Laboratoire français de Fractionnement et de Biotechnologies
  • Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: François Durand, Pr Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2015

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