Liver Cirrhosis, Liver Failure
Conditions
Keywords
cirrhosis, cirrhotic patients with acute on chronic liver failure
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
Interventions
PROCEDUREPlasma exchange with albumin
Realization of 6 plasma exchange with albumin in 11 days
Sponsors
Instituto Grifols, S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Albumin functional capacity | 10 days | Albumin binding capacity |
| Circulatory disfunction | 10 days | Plasma renin activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 blood urea nitrogen | 1 month | — |
| Plasma concentration of phosphorus | 1 month | — |
| hepatic toxins | 10 days | Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum. |
| Plasma concentration of potassium | 1 month | — |
| Hepatic encephalopathy graded with the West Haven Criteria | 1 month | — |
Countries
Spain
Outcome results
None listed