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

Vantive Health LLC

Status: Completed

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

Treatments: Device: MARS; Drug: Standard Medical Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00287235

MARS HE Study

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Group 1: Standard Medical Therapy + MARS

Experimental group

Description:

Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.

Treatment:

Drug: Standard Medical Therapy

Device: MARS

Group 2: Standard Medical Therapy Only

Active Comparator group

Description:

Patients who were randomized to Group 2 received standard medical treatment only.

Treatment:

Drug: Standard Medical Therapy