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Completed

NCT Number: NCT00764049

Single Pass Albumin Dialysis in Patients With Cirrhosis

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

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Key information

Conditions

Cirrhosis Acute on Chronic Hepatic Failure Acute-On-Chronic Liver Failure Brain Diseases Central Nervous System Diseases Digestive System Diseases Encephalopathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Hepatic Insufficiency Hepatorenal Syndrome Kidney Diseases Liver Diseases Liver Failure Liver Failure, Acute Male Urogenital Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hôpital Beaujon

Clichy, 92110, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Single pass albumin dialysis

Device

6 hours sessions of albumin dialysis.

Primary outcomes

  1. Effects on clinical and biochemical variables

    Time frame: 3 months follow-up

Secondary outcomes

  1. Safety

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DACAR

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 1, 2008
Registry last updated
Feb 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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