Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)

Study Overview
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Brief Summary
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The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2 grades compared to Standard Medical Therapy (SMT) in patients with chronic End Stage Liver Disease (ESLD) during a 5 day study period.

Detailed Description
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The trial was a two-group unblinded multicenter clinical trial. Patients were randomized to receive either SMT or SMT plus five days MARS® treatment. The trial design called for patients to receive a baseline hepatic encephalopathy (HE) assessment on admission, and at 12-hour intervals, giving 10 HE measurements during treatment using a refinement / adaptation of the Conn West Haven HE Criteria HE scoring system

Official Title
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A Prospective, Controlled Study Of The Clinical Efficacy Of Albumin Dialysis Using The Molecular Adsorbent Recirculating System (MARS®) For The Treatment Of Patients With Hepatic Encephalopathy

Conditions
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Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic, Liver Cirrhosis

Intervention / Treatment
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* Device: MARS
* Drug: Standard Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent by patient or patient's legally appointed representative Be at least 18 years of age; male or female Have chronic end stage liver disease with worsening Hepatic Encephalopathy (Grades 3,4). Exclusion Criteria: Clinically significant bleeding from gastrointestinal or other site within the last 24 hours and requires 2 or more units of blood to maintain a stable hemoglobin level Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine) On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT) Pregnancy Inability to obtain informed consent Uncontrolled sepsis as defined by hemodynamic instability Post-liver transplant Fulminant hepatic failure Irreversible brain damage as indicated by the neurologic examination and CT imaging Endocarditis Pulmonary edema Massive aspiration pneumonia secondary to Hepatic Encephalopathy Active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission Acute main portal vein thrombosis in patients with Hepatocellular Carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Standard Medical Therapy + MARS<br>Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days. | Device: MARS<br> <br> * Other names: Extracorporeal Albumin Dialysis;Drug: Standard Medical Therapy<br> <br> * Other names: SMT;|
| Active Comparator: Group 2: Standard Medical Therapy Only<br>Patients who were randomized to Group 2 received standard medical treatment only. | Drug: Standard Medical Therapy<br> <br> * Other names: SMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-point reduction in HE score from the randomization grade | The primary outcome measure was a two-point reduction in HE score from the the randomization grade (i.e. Grade 4 improved to at least Grade 2 and Grade 3 improved to at least Grade 1). Two summary statistics were used in the analysis: 1) The proportion of HE readings within the five-day treatment period showing an improvement of at least two points over baseline 2) The time from admission to the first two-point improvement in HE score. | Within the five-day treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude, duration and time of improvement in Hepatic Encephalopathy |  | Within the five-day treatment period | 
| Cognitive function and functional status of patients |  | Within the five-day treatment period | 
| Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy |  | Within the five-day treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Encephalopathy, End Stage Liver Disease, Cirrhosis, MARS, Albumin Dialysis