- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02310542
Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure (MARSPAD)
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.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
LYON cedex 4, France, 69317
- Hôpital de la Croix Rousse - Service de réanimation chirurgicale
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
|
Experimental: SPAD-MARS
Patients will receive first the SPAD albumin dialysis system and then, in a second time, the MARS albumin dialysis system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
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.
|
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)
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.
|
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)
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serge Duperret, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010.652
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Failure, Acute
-
HLB Cell Co., Ltd.UnknownAcute-On-Chronic Liver Failure | Acute Liver FailureKorea, Republic of
-
Third Affiliated Hospital, Sun Yat-Sen UniversityWithdrawnAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver FailureIndia
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute Liver Failure | Acute on Chronic Liver FailureIndia
-
Beijing Continent Pharmaceutical Co, Ltd.RecruitingAcute-On-Chronic Liver Failure | Acute Liver FailureChina
-
Chulalongkorn UniversityRecruitingAcute-On-Chronic Liver Failure | Acute on Chronic Hepatic FailureThailand
-
Tianjin Weikai Bioeng., Ltd.Tianjin Nankai HospitalUnknownLiver Failure, Acute on ChronicChina
-
University of EdinburghNHS LothianNot yet recruitingAcute on Chronic Hepatic Failure | Acute Liver Failure | Acute Liver Injury
-
Nanfang Hospital of Southern Medical UniversityCompletedLiver Injury | Liver Failure, Acute on Chronic
-
Aga Khan UniversityNational Institute of Liver & GI Diseases, PakistanNot yet recruiting
Clinical Trials on MARS albumin dialysis system
-
Baxter Healthcare CorporationGambro Renal Products, Inc.CompletedLiver Failure | Liver Cirrhosis | Hepatic Encephalopathy | Hepatitis, ChronicUnited States, Belgium, Denmark
-
Stefan Gilg, MD, PhDUnknownLiver Failure as A Complication of Care
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; Laboratoire...CompletedAcute on Chronic Hepatic Failure | Cirrhosis | Hepatorenal Syndrome | EncephalopathyFrance
-
Medical University of ViennaUnknownAcute Liver Failure | Hypoxic Hepatitis | Ischemic Hepatitis | Shock Liver | Hypoxic Liver InjuryGermany, Austria
-
University of AarhusCompletedAlcoholic HepatitisDenmark
-
Johns Hopkins UniversitySchool of Biomedical Sciences, University of Otago, Dunedin, New Zealand; D...Completed
-
Korea Health Industry Development InstituteRecruitingParkinson DiseaseKorea, Republic of
-
University of HelsinkiGE HealthcareCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Cubist Pharmaceuticals LLCGlaxoSmithKlineCompleted