Single Pass Albumin Dialysis in Patients With Cirrhosis

NCT ID: NCT00764049

Last Updated: 2015-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-07-31

Brief Summary

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The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Detailed Description

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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.

Conditions

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Cirrhosis Acute on Chronic Hepatic Failure Hepatorenal Syndrome Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1: Single pass albumin dialysis

Patients entered in the pilot study.

Group Type EXPERIMENTAL

Single pass albumin dialysis

Intervention Type DEVICE

6 hours sessions of albumin dialysis.

Interventions

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Single pass albumin dialysis

6 hours sessions of albumin dialysis.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Durand, Pr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Beaujon

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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P050902

Identifier Type: -

Identifier Source: org_study_id

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