Back to resultsEffects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"
Primary Purpose
Liver Cirrhosis, Liver Failure
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Plasma exchange with albumin
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring cirrhosis, cirrhotic patients with acute on chronic liver failure
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.
Sites / Locations
- Hospital Clínic of Barcelona
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Albumin
Arm Description
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
Outcomes
Primary Outcome Measures
Albumin functional capacity
Albumin binding capacity
Albumin functional capacity
Electron Paramagnetic Resonance Spectroscopy
Albumin functional capacity
Ischemia-modified albumin
Circulatory disfunction
Plasma renin activity
Circulatory disfunction
Plasma concentration of noradrenaline
Circulatory disfunction
Systemic hemodynamic study and portal venous pressure
Secondary Outcome Measures
Plasma concentration of blood urea nitrogen
Hepatic encephalopathy graded with the West Haven Criteria
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
Plasma concentration of serum creatinine
Plasma concentration of sodium
Plasma concentration of potassium
Plasma concentration of phosphorus
hepatic toxins
Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.
Full Information
NCT ID
NCT01201720
First Posted
August 27, 2010
Last Updated
February 5, 2019
Sponsor
Instituto Grifols, S.A.
1. Study Identification
Unique Protocol Identification Number
NCT01201720
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Grifols, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Liver Failure
Keywords
cirrhosis, cirrhotic patients with acute on chronic liver failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albumin
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Plasma exchange with albumin
Other Intervention Name(s)
Albumina grifols 5%
Intervention Description
Realization of 6 plasma exchange with albumin in 11 days
Primary Outcome Measure Information:
Title
Albumin functional capacity
Description
Albumin binding capacity
Time Frame
10 days
Title
Albumin functional capacity
Description
Electron Paramagnetic Resonance Spectroscopy
Time Frame
10 days
Title
Albumin functional capacity
Description
Ischemia-modified albumin
Time Frame
10 days
Title
Circulatory disfunction
Description
Plasma renin activity
Time Frame
10 days
Title
Circulatory disfunction
Description
Plasma concentration of noradrenaline
Time Frame
10 days
Title
Circulatory disfunction
Description
Systemic hemodynamic study and portal venous pressure
Time Frame
11 days
Secondary Outcome Measure Information:
Title
Plasma concentration of blood urea nitrogen
Time Frame
1 month
Title
Hepatic encephalopathy graded with the West Haven Criteria
Time Frame
1 month
Title
Hepatic function parameters
Description
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
Time Frame
1 month
Title
Plasma concentration of serum creatinine
Time Frame
1 month
Title
Plasma concentration of sodium
Time Frame
1 month
Title
Plasma concentration of potassium
Time Frame
1 month
Title
Plasma concentration of phosphorus
Time Frame
1 month
Title
hepatic toxins
Description
Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicente Arroyo, MD
Organizational Affiliation
Hospital Clínic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic of Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
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"
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