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Single Pass Albumin Dialysis in Patients With Cirrhosis (DACAR)

Primary Purpose

Cirrhosis, Acute on Chronic Hepatic Failure, Hepatorenal Syndrome

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Single pass albumin dialysis

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring Albumin dialysis, Artificial liver support, Acute on chronic liver failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Beaujon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1: Single pass albumin dialysis

Arm Description

Patients entered in the pilot study.

Outcomes

Primary Outcome Measures

Effects on clinical and biochemical variables

Secondary Outcome Measures

Safety

Full Information

NCT ID

NCT00764049

First Posted

September 30, 2008

Last Updated

February 24, 2015

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Laboratoire français de Fractionnement et de Biotechnologies, Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT00764049

Brief Title

Single Pass Albumin Dialysis in Patients With Cirrhosis

Acronym

DACAR

Official Title

Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Laboratoire français de Fractionnement et de Biotechnologies, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Acute on Chronic Hepatic Failure, Hepatorenal Syndrome, Encephalopathy

Keywords

Albumin dialysis, Artificial liver support, Acute on chronic liver failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1: Single pass albumin dialysis

Arm Type

Experimental

Arm Description

Patients entered in the pilot study.

Intervention Type

Device

Intervention Name(s)

Single pass albumin dialysis

Intervention Description

6 hours sessions of albumin dialysis.

Primary Outcome Measure Information:

Title

Effects on clinical and biochemical variables

Time Frame

3 months follow-up

Secondary Outcome Measure Information:

Title

Safety

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

François Durand, Pr

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Beaujon

City

Clichy

ZIP/Postal Code

92110

Country

France

12. IPD Sharing Statement

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Single Pass Albumin Dialysis in Patients With Cirrhosis

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