Single Pass Albumin Dialysis in Patients With Cirrhosis

Cirrhosis Clinical Trial

— DACAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764049
• Other study ID #: P050902
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 30, 2008
• Last updated: February 24, 2015
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute on Chronic Hepatic Failure
• Brain Diseases
• Cirrhosis
• Encephalopathy
• End Stage Liver Disease
• Hepatorenal Syndrome
• Liver Cirrhosis
• Liver Failure
• Liver Failure, Acute

Intervention

Device:
• Single pass albumin dialysis
6 hours sessions of albumin dialysis.

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, Laboratoire français de Fractionnement et de Biotechnologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on clinical and biochemical variables		3 months follow-up	Yes
Secondary	Safety		3 months	Yes