Clinical trial NCT02310542: Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure
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
Overall status: COMPLETED
Phase: NA
Conditions: Liver Failure, Acute
Chronic Hepatic Failure
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Comparison of total plasmatic bilirubin level before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
timeFrame: 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:
measure: Comparison of bile acids and conjugated bilirubin levels before and after two albumin dialysis systems: with recirculation (MARS™ system) and without recirculation (SPAD™ system).
timeFrame: 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.
measure: Comparison of hepatic encephalopathy score before and after two albumin dialysis systems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
timeFrame: 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.
measure: 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)
timeFrame: 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
measure: Comparison of tolerance of two albumin dialysis sytems : with recirculation (MARS™ system) and without recirculation (SPAD™ system)
timeFrame: 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.
Other outcomes:
Locations:
city: LYON cedex 4
country: France
facility: Hôpital de la Croix Rousse - Service de réanimation chirurgicale
Study officials:
affiliation: Hospices Civils de Lyon
name: Serge Duperret, MD
role: PRINCIPAL_INVESTIGATOR
References: