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"
- Conditions
- Liver CirrhosisLiver Failure
- Interventions
- Procedure: Plasma exchange with albumin
- Registration Number
- NCT01201720
- Lead Sponsor
- Instituto Grifols, S.A.
- 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-on-chronic liver failure".
- 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-on-chronic liver failure", renal disfunction, cerebral disfunction ,and inflamtory response
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Albumin Plasma exchange with albumin 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
- Primary Outcome Measures
Name Time Method Albumin functional capacity 10 days Ischemia-modified albumin
Circulatory disfunction 11 days Systemic hemodynamic study and portal venous pressure
- Secondary Outcome Measures
Name Time Method hepatic toxins 10 days Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.
Plasma concentration of blood urea nitrogen 1 month Hepatic function parameters 1 month Conventional hepatic function parameters: aspartate transaminase, alanine transaminase, gamma-glutamyl transferase, alkaline phosphatase, total, conjugated and not conjugated serum bilirubin, serum albumin, international normalized ratio (INR) and prothrombin index
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 Hepatic encephalopathy graded with the West Haven Criteria 1 month
Trial Locations
- Locations (1)
Hospital Clínic of Barcelona
🇪🇸Barcelona, Spain