Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"

Grifols

Status: Completed

Conditions: Liver Failure; Liver Cirrhosis

Treatments: Procedure: Plasma exchange with albumin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01201720

2010-021360-15 (EudraCT Number)

IG0905

Details and patient eligibility

About

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".

Full description

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Albumin

Other group

Description:

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

Treatment:

Procedure: Plasma exchange with albumin