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

Primary Purpose

Liver Failure, Acute, Chronic Hepatic Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MARS albumin dialysis system
SPAD albumin dialysis system
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure, Acute

Eligibility Criteria

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

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

Sites / Locations

  • Hôpital de la Croix Rousse - Service de réanimation chirurgicale

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MARS-SPAD

SPAD-MARS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Comparison of total plasmatic bilirubin level before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Determination of total plasmatic bilirubin level will be performed by arterial sample and expressed in µmol/liter. Total plasmatic bilirubin purification will be compared between the two dialysis systems: total plasmatic bilirubin level will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.

Secondary Outcome Measures

Comparison of bile acids and conjugated bilirubin levels before and after two albumin dialysis systems: with recirculation (MARS™ system) and without recirculation (SPAD™ system).
Determination of bile acids and conjugated bilirubin levels will be performed by arterial sample and expressed in µmol/liter. Bile acids and conjugated bilirubin purifications will be compared between the two dialysis systems: Bile acids and conjugated bilirubin levels will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Comparison of hepatic encephalopathy score before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Determination of hepatic encephalopathy score will be performed by clinical evaluation. Hepatic encephalopathy score will be compared between the two dialysis systems: hepatic encephalopathy score will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Comparison of pulsatility index of middle cerebral artery recorded by transcranial doppler before and after two albumin dialysis system : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Pulsatility index of middle cerebral artery will be recorded by transcranial doppler. Pulsatility index of middle cerebral artery will be compared between the two dialysis systems: Pulsatility index of middle cerebral artery will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Comparison of tolerance of two albumin dialysis sytems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Tolerance will be evaluated by effect of albumin dialysis on coagulation indices : prothrombin time (seconds) and international normalized ratio, activated partial thromboplastin time ratio, fibrinogen level (g/L), factor V level (%), platelet count (×10(9) /L), hemoglobin level (g/L), red cell count (10(12)/L), hematocrit level (%). Coagulation indices will be measured by an arterial sample before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.

Full Information

First Posted
November 14, 2014
Last Updated
February 27, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02310542
Brief Title
Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure
Acronym
MARSPAD
Official Title
Comparison of Two Extracorporeal Liver Support System (With or Without Recirculation) : MARS (Molecular Adsorbents Recirculating System) Versus SPAD (Single Pass Albumin Dialysis) in Severe Liver Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Acute, Chronic Hepatic Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MARS-SPAD
Arm Type
Experimental
Arm Description
Patients will receive first the MARS albumin dialysis system and then, in a second time, the SPAD albumin dialysis system.
Arm Title
SPAD-MARS
Arm Type
Experimental
Arm Description
Patients will receive first the SPAD albumin dialysis system and then, in a second time, the MARS albumin dialysis system.
Intervention Type
Device
Intervention Name(s)
MARS albumin dialysis system
Intervention Type
Device
Intervention Name(s)
SPAD albumin dialysis system
Primary Outcome Measure Information:
Title
Comparison of total plasmatic bilirubin level before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Description
Determination of total plasmatic bilirubin level will be performed by arterial sample and expressed in µmol/liter. Total plasmatic bilirubin purification will be compared between the two dialysis systems: total plasmatic bilirubin level will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Time Frame
Before and at the end of a MARS™ dialysis (8h) and before and at the end of a SPAD™ system dialysis (10h). Participants will be followed for the duration of critical care stay, an expected average of 1 week
Secondary Outcome Measure Information:
Title
Comparison of bile acids and conjugated bilirubin levels before and after two albumin dialysis systems: with recirculation (MARS™ system) and without recirculation (SPAD™ system).
Description
Determination of bile acids and conjugated bilirubin levels will be performed by arterial sample and expressed in µmol/liter. Bile acids and conjugated bilirubin purifications will be compared between the two dialysis systems: Bile acids and conjugated bilirubin levels will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Time Frame
Before and at the end of a MARS™ system dialysis (8h) and before and at the end of a SPAD™ dialysis (10h) . Participants will be followed for the duration of critical care stay, an expected average of 1 week.
Title
Comparison of hepatic encephalopathy score before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Description
Determination of hepatic encephalopathy score will be performed by clinical evaluation. Hepatic encephalopathy score will be compared between the two dialysis systems: hepatic encephalopathy score will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Time Frame
Before and at the end of a MARS™ system dialysis (8h) and before and at the end of a SPAD™ system dialysis (10h) . Participants will be followed for the duration of critical care stay, an expected average of 1 week.
Title
Comparison of pulsatility index of middle cerebral artery recorded by transcranial doppler before and after two albumin dialysis system : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Description
Pulsatility index of middle cerebral artery will be recorded by transcranial doppler. Pulsatility index of middle cerebral artery will be compared between the two dialysis systems: Pulsatility index of middle cerebral artery will be measured before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Time Frame
Before and at the end of a MARS™ dialysis (8h) and before and at the end of a SPAD™ system dialysis (10h). Participants will be followed for the duration of critical care stay, an expected average of 1 week
Title
Comparison of tolerance of two albumin dialysis sytems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
Description
Tolerance will be evaluated by effect of albumin dialysis on coagulation indices : prothrombin time (seconds) and international normalized ratio, activated partial thromboplastin time ratio, fibrinogen level (g/L), factor V level (%), platelet count (×10(9) /L), hemoglobin level (g/L), red cell count (10(12)/L), hematocrit level (%). Coagulation indices will be measured by an arterial sample before and at the end of MARS™ dialysis (8 hours) and before and at the end of SPAD™ dialysis (10 hours) ; the two variations will be compared. Each patient will receive the two dialysis systems separated by a free interval that will last between 12 and 48 hours.
Time Frame
During MARS™ system dialysis (8h) and during SPAD™ system dialysis (10h) . Participants will be followed for the duration of critical care stay, an expected average of 1 week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Duperret, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Croix Rousse - Service de réanimation chirurgicale
City
LYON cedex 4
ZIP/Postal Code
69317
Country
France

12. IPD Sharing Statement

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

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