Hepatic Encephalopathy, Hepatitis, Chronic, Liver Cirrhosis, Liver Failure
Conditions
Keywords
Hepatic Encephalopathy, End Stage Liver Disease, Cirrhosis, MARS, Albumin Dialysis
Brief summary
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
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
Interventions
DEVICEMARS
DRUGStandard Medical Therapy
Sponsors
Gambro Renal Products, Inc.
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent by patient or patient's legally appointed representative 2. Be at least 18 years of age; male or female 3. Have chronic end stage liver disease with worsening Hepatic Encephalopathy (Grades 3,4).
Exclusion criteria
1. 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 2. Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine) 3. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT) 4. Pregnancy 5. Inability to obtain informed consent 6. Uncontrolled sepsis as defined by hemodynamic instability 7. Post-liver transplant 8. Fulminant hepatic failure 9. Irreversible brain damage as indicated by the neurologic examination and CT imaging 10. Endocarditis 11. Pulmonary edema 12. Massive aspiration pneumonia secondary to Hepatic Encephalopathy 13. Active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission 14. Acute main portal vein thrombosis in patients with Hepatocellular Carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-point reduction in HE score from the randomization grade | Within the five-day treatment period | 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. |
Secondary
| Measure | 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 |
Countries
Belgium, Denmark, United States
Outcome results
None listed