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

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Liver Failure

Conditions
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Liver Cirrhosis, Liver Failure

Intervention / Treatment
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* Procedure: Plasma exchange with albumin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Albumin<br>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 | Procedure: Plasma exchange with albumin<br>* Realization of 6 plasma exchange with albumin in 11 days<br>* Other names: Albumina grifols 5%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Albumin functional capacity | Albumin binding capacity | 10 days | 
| Albumin functional capacity | Electron Paramagnetic Resonance Spectroscopy | 10 days | 
| Albumin functional capacity | Ischemia-modified albumin | 10 days | 
| Circulatory disfunction | Plasma renin activity | 10 days | 
| Circulatory disfunction | Plasma concentration of noradrenaline | 10 days | 
| Circulatory disfunction | Systemic hemodynamic study and portal venous pressure | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of blood urea nitrogen |  | 1 month | 
| Hepatic encephalopathy graded with the West Haven Criteria |  | 1 month | 
| Hepatic function parameters | 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 | 1 month | 
| Plasma concentration of serum creatinine |  | 1 month | 
| Plasma concentration of sodium |  | 1 month | 
| Plasma concentration of potassium |  | 1 month | 
| Plasma concentration of phosphorus |  | 1 month | 
| hepatic toxins | Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis, cirrhotic patients with acute on chronic liver failure