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"

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

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".

Study Overview

• Status: Completed
• Conditions: Liver Failure; Liver Cirrhosis
• Intervention / Treatment: Procedure: Plasma exchange with albumin

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Clinic of Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Procedure: Plasma exchange with albumin; Realization of 6 plasma exchange with albumin in 11 days; Other Names: Albumina grifols 5%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Grifols, S.A.
• Investigators: Principal Investigator: Vicente Arroyo, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 27, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 15, 2010

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cirrhosis; cirrhotic patients with acute on chronic liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Fibrosis; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Liver Cirrhosis
• Other Study ID Numbers: IG0905; 2010-021360-15 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No