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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2004-04-30

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.

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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

Conditions

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Hepatic Encephalopathy Liver Failure Hepatitis, Chronic Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Standard Medical Therapy + MARS

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

Group Type EXPERIMENTAL

MARS

Intervention Type DEVICE

Standard Medical Therapy

Intervention Type DRUG

Group 2: Standard Medical Therapy Only

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

Group Type ACTIVE_COMPARATOR

Standard Medical Therapy

Intervention Type DRUG

Interventions

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MARS

Intervention Type DEVICE

Standard Medical Therapy

Intervention Type DRUG

Other Intervention Names

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ECAD Extracorporeal Albumin Dialysis SMT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No