NCT01201720已完成不适用
Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Liver Failure"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Circulatory disfunction
研究概览
简要总结
The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".
详细描述
The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure", renal disfunction, cerebral disfunction ,and inflamtory response
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 80 years old
- •Hepatic cirrhosis diagnosed by biopsy or clinical, analytic and ultra sound data.
- •acute on chronic liver failure: defined by an acute deterioration in hepatic function produced in 2-4 weeks with jaundice (total serum bilirubin ≥ 5 mg/dl ) and hepatic encephalopathy (≥ grade 2) and/or renal insufficiency (serum creatinine ≥ 2 mg/dl)
排除标准
- •Neoplasm disease including hepatocarcinoma which exceed Milan criteria (1 tumour > 5cm, up to 3 tumours <3 cm)
- •Active bacterial or fungal infection with hemodynamic instability which require the utilization of vasoactive drugs at moderate dose (>0,5 μg/Kg/min of noradrenaline)
- •Structural moderate to severe cardiopathy (Cardiac Index <2l/min/m2)
- •Chronic renal insufficiency in treatment with haemodialysis
- •Chronic moderate o severe pulmonary disease (maximum expiratory volume in a second <50%)
- •Active transplant
- •human immunodeficiency virus infection
- •Pregnancy or lactation
- •Acute respiratory distress syndrome (P02/Fi02< 200mm Hg) or acute lung injury (P02/Fi02< 300mm Hg)
- •Hemodynamic instability (>0,5 μg/Kg/min of noradrenaline)
- •Bleeding in the digestive tract in the previous 72h to the treatment
- •Severe coagulopathy: INR ≥ 3.0 (Quick ≤ 20%) and/or platelets < 30000//mm3
- •Extrahepatic cholestasis
- •Hepatobiliary surgery in the last 6 months (except laparoscopic Cholecystectomy)
- •Concentrations bilirubin ≥ 5mg/dl during the period above 4 weeks previous to inclusion
- •Concomitant participation in an other clinical trial
- •Drug addiction
- •Mental status which does not allow the patient to understand the trial, with the exception of hepatic encephalopathy.
研究组 & 干预措施
Albumin
Other
Albumin solution for infusion 5%. dosage: 43,5 millimole intravenouse use , 6 plasma exchange with albumin in 11 days and administration of polyclonal gamma globulin.6 sessions
干预措施: Plasma exchange with albumin (Procedure)
结局指标
主要结局
Circulatory disfunction
时间窗: 11 days
Systemic hemodynamic study and portal venous pressure
Albumin functional capacity
时间窗: 10 days
Albumin binding capacity
次要结局
- Hepatic encephalopathy graded with the West Haven Criteria(1 month)
- hepatic toxins(10 days)
- Plasma concentration of blood urea nitrogen(1 month)
- Hepatic function parameters(1 month)
- Plasma concentration of serum creatinine(1 month)
- Plasma concentration of sodium(1 month)
- Plasma concentration of phosphorus(1 month)
- Plasma concentration of potassium(1 month)
研究者
研究点 (2)
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