Status:
COMPLETED
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"
Lead Sponsor:
Instituto Grifols, S.A.
Conditions:
Liver Cirrhosis
Liver Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01201720
Start Date
March 1 2011
End Date
February 1 2013
Last Update
February 7 2019
Active Locations (1)
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1
Hospital Clínic of Barcelona
Barcelona, Spain, 08028