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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Two-point reduction in HE score from the randomization grade
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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)
- •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
研究组 & 干预措施
Group 2: Standard Medical Therapy Only
Patients who were randomized to Group 2 received standard medical treatment only.
干预措施: Standard Medical Therapy (Drug)
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.
干预措施: MARS (Device)
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.
干预措施: Standard Medical Therapy (Drug)
结局指标
主要结局
Two-point reduction in HE score from the randomization grade
时间窗: 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.
次要结局
- 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)