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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-02-28

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".

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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

Conditions

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Liver Cirrhosis Liver Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Plasma exchange with albumin

Intervention Type PROCEDURE

Realization of 6 plasma exchange with albumin in 11 days

Interventions

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Plasma exchange with albumin

Realization of 6 plasma exchange with albumin in 11 days

Intervention Type PROCEDURE

Other Intervention Names

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Albumina grifols 5%

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes