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Single Pass Albumin Dialysis in Patients With Cirrhosis

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Disease Information

Descriptive Information
Brief Title † Single Pass Albumin Dialysis in Patients With Cirrhosis
Official Title † 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 Phase Phase 1/Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Effects on clinical and biochemical variables
Secondary Outcome Measure † Safety
Condition † Cirrhosis Acute on Chronic Hepatic Failure Hepatorenal Syndrome Encephalopathy
Intervention † DeviceSingle pass albumin dialysis
Study Arms / Comparison Groups 1: Single pass albumin dialysis Patients entered in the pilot study.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 11
Start Date † June 2009
Completion Date July 2012
Primary Completion Date January 2012
Eligibility 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.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † France
Administrative Information
NCT ID † NCT00764049
Organization ID P050902
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Assistance Publique - Hôpitaux de Paris
Collaborators †† Laboratoire français de Fractionnement et de Biotechnologies
Investigators † Principal Investigator: François Durand, Pr, Assistance Publique - Hôpitaux de Paris
Information Provided By
Verification Date February 2015
First Received Date † September 30, 2008
Last Updated Date February 24, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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