Clinical trial NCT01201720: 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"
Official title: Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Liver Failure"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Liver Failure
Keywords: cirrhosis
cirrhotic patients with acute on chronic liver failure
Lead sponsor: Grifols Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Albumin functional capacity
timeFrame: 10 days
measure: Albumin functional capacity
timeFrame: 10 days
measure: Albumin functional capacity
timeFrame: 10 days
measure: Circulatory disfunction
timeFrame: 10 days
measure: Circulatory disfunction
timeFrame: 10 days
measure: Circulatory disfunction
timeFrame: 11 days
Secondary outcomes:
measure: Plasma concentration of blood urea nitrogen
timeFrame: 1 month
measure: Hepatic encephalopathy graded with the West Haven Criteria
timeFrame: 1 month
measure: Hepatic function parameters
timeFrame: 1 month
measure: Plasma concentration of serum creatinine
timeFrame: 1 month
measure: Plasma concentration of sodium
timeFrame: 1 month
measure: Plasma concentration of potassium
timeFrame: 1 month
measure: Plasma concentration of phosphorus
timeFrame: 1 month
measure: hepatic toxins
timeFrame: 10 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic of Barcelona
Study officials:
affiliation: Hospital Clínic of Barcelona
name: Vicente Arroyo, MD
role: PRINCIPAL_INVESTIGATOR
References: