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

NCT02310542 | Completed

• 1 other identifier: 2010.652
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Failure, Acute; Chronic Hepatic Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (4)

• Comparison of bile acids and conjugated bilirubin levels before and after two albumin dialysis systems: with recirculation (MARS™ system) and without recirculation (SPAD™ system).

  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.

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

  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.

• 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)

  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

• Comparison of tolerance of two albumin dialysis sytems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)

  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.

Study Arms (2)

MARS-SPAD

EXPERIMENTAL

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

SPAD-MARS

EXPERIMENTAL

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

Interventions

MARS albumin dialysis system DEVICE

MARS-SPAD; SPAD-MARS

SPAD albumin dialysis system DEVICE

MARS-SPAD; SPAD-MARS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse - Service de réanimation chirurgicale

Lyon, 69317, France

Location

Related Publications (1)

• Wallon G, Guth C, Guichon C, Thevenon S, Gazon M, Viale JP, Schoeffler M, Duperret S, Aubrun F. Extracorporeal Albumin Dialysis in Liver Failure with MARS and SPAD: A Randomized Crossover Trial. Blood Purif. 2022;51(3):243-250. doi: 10.1159/000515825. Epub 2021 Jun 17.

  PMID: 34139706 RESULT

MeSH Terms

Conditions

Liver Failure, Acute; End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Serge Duperret, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: December 8, 2014
• Study Start: December 1, 2011
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (1)