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

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ClinicalTrials.gov Identifier: NCT02310542
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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).


Condition or disease Intervention/treatment Phase
Liver Failure, Acute Chronic Hepatic Failure Device: MARS albumin dialysis system Device: SPAD albumin dialysis system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Albumins

Arms and Interventions
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Arm Intervention/treatment
Experimental: MARS-SPAD
Patients will receive first the MARS albumin dialysis system and then, in a second time, the SPAD albumin dialysis system.
 Device: MARS albumin dialysis system
Device: SPAD albumin dialysis system
Experimental: SPAD-MARS
Patients will receive first the SPAD albumin dialysis system and then, in a second time, the MARS albumin dialysis system.
 Device: MARS albumin dialysis system
Device: SPAD albumin dialysis system


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of total plasmatic bilirubin level before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system) [ 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 ]
    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 :
  1. Comparison of bile acids and conjugated bilirubin levels before and after two albumin dialysis systems: with recirculation (MARS™ system) and without recirculation (SPAD™ system). [ 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. ]
    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.

  2. Comparison of hepatic encephalopathy score before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system) [ 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. ]
    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.

  3. 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) [ 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 ]
    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.

  4. Comparison of tolerance of two albumin dialysis sytems : with recirculation (MARS™ system) and without recirculation (SPAD™ system) [ 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310542


Locations
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France
Hôpital de la Croix Rousse - Service de réanimation chirurgicale
LYON cedex 4, France, 69317
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Serge Duperret, MD Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02310542    
Other Study ID Numbers: 2010.652
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Failure, Acute
Liver Diseases
Digestive System Diseases