Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure

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

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-09-30

Brief Summary

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A critical issue of the clinical syndrome in liver failure is the accumulation of toxins not cleared by the failing liver. Based on this hypothesis, albumin dialysis is used to remove those substances. Albumin dialysis with recirculation (MARS) is the most used system but required specific system and expert environment. Alternative system without recirculation (SPAD) is less expensive and can be realised in critical care services trained to extrarenal epuration. The primary objective of this study is to compare biological and clinical efficacy, pulsatility index of middle cerebral artery modification and tolerance of both systems.

This is a prospective, open, cross-over comparative study of two albumin dialysis system. Each patient will receive the two systems in an randomly assessed order. Patients are divided up according to bilirubin plasmatic level. (250µmol/L to 400 µmol/L and \>400µmol/L).

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Detailed Description

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Conditions

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Liver Failure, Acute Chronic Hepatic Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MARS-SPAD

Patients will receive first the MARS albumin dialysis system and then, in a second time, the SPAD albumin dialysis system.

Group Type EXPERIMENTAL

MARS albumin dialysis system

Intervention Type DEVICE

SPAD albumin dialysis system

Intervention Type DEVICE

SPAD-MARS

Patients will receive first the SPAD albumin dialysis system and then, in a second time, the MARS albumin dialysis system.

Group Type EXPERIMENTAL

MARS albumin dialysis system

Intervention Type DEVICE

SPAD albumin dialysis system

Intervention Type DEVICE

Interventions

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MARS albumin dialysis system

Intervention Type DEVICE

SPAD albumin dialysis system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* severe hepatic failure on acute liver failure or acute on chronic liver failure
* hyperbilirubinemia (total plasmatic bilirubin level above 250µmol/L)
* hepatic encephalopathy or pruritus or hepatorenal syndrome.
* waiting for liver function recovery or liver transplantation
* Signed written informed consent by patient or patient's legally appointed representative or reliable person
* affiliation to social security

Exclusion Criteria

* contraindication to extra-renal epuration
* hypersensibility to albumin or excipients
* patients for whom 2 albumin dialysis treatment cannot be considered

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No